Teva Announces Results from Study of New Dosage of Glatiramer Acetate for Relapsing-Remitting MS

June 15, 2012 By

On June 14, 2012, Teva Pharmaceuticals Industries Ltd. announced positive results from a Phase III trial assessing the safety and efficacy of 40 mg/1 ml Copaxone (glatiramer acetate) injection. The study found that Copaxone injection administered subcutaneously three times per week significantly reduced disease activity in relapsing-remitting multiple sclerosis (RRMS) patients compared to placebo.

The one-year study consisted of over 1,400 patients. Patients treated with Copaxone exhibited a significantly reduced annualized relapse rate by 34.4% compared to patients treated with placebo. The 40 mg / 1 ml injection assessed in the study is higher than the currently marketed 20 mg/1 ml daily Copaxone.

Serge Stankovic, Senior Vice President of Clinical Research, Global Branded R&D,?Teva Pharmaceutical Industries Ltd., said, ?We are pleased with the results of this study that show the potential of 40 mg/1 ml glatiramer acetate to offer patients an effective and safe treatment option with COPAXONE? using a more convenient dosing regimen.?

Teva?s press release stated that analyses of the study are ongoing and results will be presented in the near future. The most commonly reported adverse events associated with Copaxone treatment in this study were injection site reactions, headaches, and nasopharyngitis.

Analysis:

Copaxone is indicated for the reduction of the frequency of relapses in relapsing-remitting MS, including patients who have experienced a first clinical episode and have MRI features consistent with MS. Copaxone was FDA approved on December 20, 1996 and is marketed by Teva Pharmaceuticals.

Using data from AERS, from 01/01/2004 to 3/31/2012, aggregated and standardized by the AdverseEvent RxFilter process, we identified 5,648 patients who experienced a serious adverse event where Copaxone was identified as a suspect drug causing the event and 3,986 patients who experienced a serious adverse event where Copaxone was identified as the primary suspect. The most commonly reported side effects were multiple sclerosis relapse, dyspnea (shortness of breath), and urticarial (hives). We identified 1,315 hospitalizations and 185 deaths where Copaxone was identified as the primary suspect.

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Azilect Data to be Presented at International Congress of Parkinson?s Disease and Movement Disorders

June 15, 2012 By

On June 13, 2012, Teva Pharmaceuticals Industries Ltd. announced that data from studies of Azilect (rasagiline mesylate), a MAO-B inhibitor, will be presented at the 16th Annual Internation Congress of Parkinson?s Disease and Movement Disorders, held in Dublin, Ireland, June 17-21, 2012. Teva said that over fifteen abstracts will be presented, including data from current and completed studies of Azilect and Parkinson?s disease (PD).

Analysis:

Azilect is a once-daily tablet indicated for the treatment of the signs and symptoms of idiopathic PD as initial therapy alone and as adjunct therapy to levodopa later in disease progression in patients with end-of-dose fluctuations. ?Azilect was FDA approved on May 16, 2006 and is marketed by Teva Neuroscience, Inc.

Using data from AERS, from 01/01/2004 to 3/31/2012, aggregated and standardized by the AdverseEvent RxFilter process, we identified 987 patients who experienced a serious adverse event where Azilect was identified as a suspect drug causing the event and 423 patients who experienced a serious adverse event where Azilect was identified as the primary suspect. The most commonly reported side effects were drug interaction, dizziness, and blood pressure increased. We identified 66 hospitalizations and 18 deaths where Azilect was identified as the primary suspect.

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Gilenya Shows Long-Term Efficacy and Safety in Novartis Study

June 14, 2012 By

On June 11, 2012, Novartis announced results of a phase III study of Gilenya (fingolimod) that found that Gilenya was efficacious and safe for up to 4.5 years of continuous treatment. The study also found that efficacy was improved in patients who switched to Gilenya from the multiple sclerosis (MS) medicine Avonex (interferon-beta-1a IM). The data was presented at the 22nd Annual Meeting of the European Neurological Society (ENS).

In the TRANSFORM study, patients treated with Gilenya had a reduction in the number of relapses compared to patients treated with interferon-beta-1a IM. In the extension study, it was found that the low relapse rate in patients receiving continuous treatment with Gilenya was sustained for up to 4.5 years. Patients treated with Gilenya continuously also maintained a low brain atrophy rate (measured by assessing brain volume loss). For patients who switched to Gilenya treatment after being treated with interferon-beta-1a IM, the rate of brain atrophy slowed after the switch to Gilenya.

Data from the extension study from up to 4.5 years found that Gilenya was well-tolerated and the safety profile was consistent with pivotal trials. As in previous studies, the most common adverse events associated with Gilenya treatment were nasopharyngitis, headache, and upper respiratory tract infections.

Analysis:

Gilenya is indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability. Gilenya was FDA approved on September 21, 2010 and is marketed by Novartis. It is the only oral therapy approved to treat patients with relapsing forms of MS.

Avonex is an interferon beta indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Avonex was FDA approved on May 17, 1996 and is marketed by Biogen Idec.

Using data from AERS, from 01/01/2004 to 3/31/2012, aggregated and standardized by the AdverseEvent RxFilter process, we identified 4,942 patients who experienced a serious adverse event where Gilenya was identified as a suspect drug causing the event and 4,814 patients who experienced a serious adverse event where Gilenya was identified as the primary suspect. The most commonly reported side effects were fatigue, headache, nausea. We identified 693 hospitalizations and 53 deaths where Gilenya was identified as the primary suspect.

We identified?52,293 patients who experienced a serious adverse event where Avonex was identified as a suspect drug causing the event and 42,725 patients who experienced a serious adverse event where Avonex was identified as the primary suspect. The most commonly reported side effects were influenza like illness, multiple sclerosis relapse, and fall. We identified 21,517 hospitalizations and 2,859 deaths where Avonex was identified as the primary suspect.

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Amylin Announces Symlin Helps Patients with Diabetes Achieve More Time in Normal Glucose Range

June 11, 2012 By

On June 9, 2012, Amylin Pharmaceuticals announced the results from data analyses of clinical trials?which found?that patients with type 1 or type 2 diabetes had a greater proportion of blood glucose measurements within the normal range when treated with Symlin (pramlintide acetate) and insulin. The results are being presented at the 72nd Scientific Sessions of the American Diabetes Association (ADA).

The clinical data analysis?of patients with type 2 diabetes consisted of 138 participants. According to ADA guidelines for the normal range of blood glucose measurements, patients treated with Symlin for six months had an increase in proportion of measurements in the normal range from 37.2% to 54.6%. According to American Association of Clinical Endocrinologists (AACE) guidelines, the proportion of measurements in the normal range increased from 19.7% to 28.4%. Patients treated with Symlin also achieved a decrease in the proportion of measurements in the hyperglycemic range from 61.3% to 41.9%, using ADA guidelines, and from 78.8% to 68.1%m using AACE guidelines.

Analyses of two studies of patients with type 1 diabetes found similar improvements with Symlin treatment. The percent of measurements in the normal range for a study of 218 patients increased from 44.3% to 52.5% (ADA) at six months and from 27.7% to 32.7% (AACE). An analysis of 248 patients found that measurements in the normal range increased from 37.3% to 43.9% (ADA) in Symlin treated patients compared to an increase from 38.2% to 40.9% in patients receiving placebo. ?Based on AACE criteria, the percent of measurements in the normal range increased from 22.6% to 27.8% in patients treated with Symlin compared to an increase from 24.1% to 25.0% in patients receiving placebo.

In these studies, the most common adverse event was nausea.

Analysis:

Symlin is an antihyperglycemic drug indicated for type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. It is also indicated for type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin. Symlin is given at mealtimes and was FDA approved on March 16, 2005.

Using data from AERS, from 01/01/2004 to 12/31/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 2,252 patients who experienced a serious adverse event where Symlin was identified as a suspect drug causing the event and 2,017 patients who experienced a serious adverse event where Symlin was identified as the primary suspect. The most commonly reported side effects were blood glucose increased, nausea, and blood glucose decreased. We identified 150 hospitalizations and 13 deaths where Symlin was identified as the primary suspect.

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Actemra Improved Rheumatoid Arthritis Signs and Symptoms More Than Humira as Monotherapy

June 7, 2012 By

On June 5, 2012, Genentech, a member of the Roche group, announced results from the ADACTA study that found that patients with adult rheumatoid arthritis (RA) who were treated with Actemra (tocilizumab), as single-agent therapy, achieved an improvement in disease activity compared to patients treated with Humira (adalimumab) as single-agent therapy.

The results of the ADACTA study will be presented at the annual European League Against Rheumatism (EULAR) conference on Friday. The study consisted of over 300 adult patients with severe active RA and intolerance or inadequate response to the methotrexate. Patients with RA are often treated with multiple medicines, combining biologic treatments and methotrexate. However, patients intolerant to methotrexate must receive a biologic therapy as a single agent.

The ADACTA study found that, after 24 weeks of treatment, adult patients with severe active RA, who were intolerant or did not respond adequately to methotrexate, experienced a mean improvement in disease activity with Actemra versus adalimumab, and 40% of Actemra treated patients had a DAS28 (a measure of RA disease activity) remission rate compared to 11% of adalimumab treated patients. Patients treated with Actemra also achieved a greater reduction in tender and swollen joints compared to patients treated with adalimumab.

Analysis:

Actemra is an interleukin-6 (IL-6) inhibitor indicated for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more TNF antagonist therapies and for the treatment of patients 2 years of age and older with systemic juvenile idiopathic arthritis (SJIA). Actemra was FDA approved on June 8, 2010 and is marketed by Genentech.

Adalimumab is marketed by Abbott Laboratories under the trade name Humira. Humira is a tumor necrosis factor (TNF) blocker indicated for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn?s disease (CD), and plaque psoriasis (Ps). Humira was first FDA approved on December 31, 2002 for the treatment of RA.

Using data from AERS, from 01/01/2004 to 12/31/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 2,482 patients who experienced a serious adverse event where Actemra was identified as a suspect drug causing the event and 2,280 patients who experienced a serious adverse event where Actemra was identified as the primary suspect. The most commonly reported side effects were pneumonia, death, and arthralgia (joint pain ? noninflammatory). We identified 1,165 hospitalizations and 290 deaths where Actemra was identified as the primary suspect.

We identified 77,384 patients who experienced a serious adverse event where Humira was identified as a suspect drug causing the event and 73,939 patients who experienced a serious adverse event where Humira was identified as the primary suspect. The most commonly reported side effects were injection site pain, incorrect dose administered, and drug ineffective. We identified 14,994 hospitalizations and 2,671 deaths where Humira was identified as the primary suspect.

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Novartis Studies Find ACZ885 Helps Relieve Symptoms in Patients with SJIA and in Patients with TRAPS

June 6, 2012 By

On June 6, 2012, Novartis announced?the results of?two clinical trials of ACZ885 (canakinumab), trade name Ilaris. Both trials, a Phase III study in patients with systemic juvenile idiopathic arthritis (SJIA) and a Phase II study in patients with tumor necrosis factor (TNF) receptor-associated period syndrome (TRAPS), met their primary endpoints and the results of both will be presented at the 2012 European League Against Rheumatism (EULAR) conference.

The Phase III study of patients with SJIA found that 62% of SJIA patients treated with ACZ885 were symptom-free at the end of the placebo-controlled period. Of patients treated with ACZ885 who were then randomized to receive placebo, 32% were symptom-free at the end of this period. Additionally, one-third of SJIA patients treated with ACZ885 for five months were able to become steroid-free.

In the Phase II Study of patients with TEAPS, 90% of patients treated with ACZ885 experienced clinical remission after one week of treatment. Ninety-five percent of patients treated with ACZ885 experienced a complete or almost complete response after two weeks of treatment.

Analysis:

ACZ885 is a fully human monoclonal antibody that inhibits IL-1 beta. IL-1 beta plays a role in the inflammatory response in SJIA and TRAPS. ACZ885 is marketed under the trade name Ilaris and is indicated for the treatment of adults and pediatric patients 4 years and older for the treatment of cryopyrin-associated periodic syndromes (CAPS). ACZ885 was FDA approved on June 17, 2009.

Using data from AERS, from 01/01/2004 to 12/31/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 148 patients who experienced a serious adverse event where ACZ885 was identified as a suspect drug causing the event and 141 patients who experienced a serious adverse event where ACZ885 was identified as the primary suspect. The most commonly reported side effects were pyrexia, pneumonia, and cough. We identified 101 hospitalizations and 11 deaths where ACZ885 was identified as the primary suspect.

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Amylin Pharmaceuticals Announces that it will Present Data for Bydureon, Byetta, and Symlin at ADA Meeting

June 6, 2012 By

On June 4, 2012, Amylin Pharmaceuticals, Inc. announced that the company will present data for Bydureon (exenatide extended-release for injectable suspension), Byetta (exenatide), and Symlin (pramlintide acetate) injection at the 72nd Scientific Sessions of the American Diabetes Association (ADA), held in Philadelphia.

Results from 13 abstracts will be presented at the conference detailing new information about Bydureon, Byetta, and Symlin, in addition to further research into the exenatide sales process. Data on Byetta will be presented at the 2012 Joint ADA/The Lancet Symposium, and?further information on long-acting?glucagon-like peptide-1 (GLP-1) receptor agonist therapy will be featured at a corporate convention.

Daniel M. Bradbury, president and chief executive officer,?Amylin Pharmaceuticals, said, “Multiple presentations at this year’s meeting demonstrate the durability of effect and long-term safety and tolerability of BYDUREON and BYETTA, as well as provide important insights into the effect of SYMLIN on glucose targets.?

Analysis:

Bydureon is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. It is an extended-release formulation of exenatide and should not be co-administered with Byetta. Bydureon is administered by subcutaneous injection once a week. Bydureon was FDA approved on January 27, 2012.

Byetta is also a GLP-1 receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ?Byetta was the first GLP-1 receptor agonist to be FDA approved for the treatment of type 2 diabetes. Byetta is administered by subcutaneous injection twice daily. Byetta was FDA approved on April 28, 2005.

Symlin is an antihyperglycemic drug indicated for type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. It is also indicated for type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin. Symlin is given at mealtimes and was FDA approved on March 16, 2005.

Using data from AERS, from 01/01/2004 to 12/31/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 38,156 patients who experienced a serious adverse event where Byetta was identified as a suspect drug causing the event and 36,309 patients who experienced a serious adverse event where Byetta was identified as the primary suspect. The most commonly reported side effects were blood glucose increased, weight decreased, and nausea. We identified 4,328 hospitalizations and 327 deaths where Byetta was identified as the primary suspect.

We identified 2,252 patients who experienced a serious adverse event where Symlin was identified as a suspect drug causing the event and 2,017 patients who experienced a serious adverse event where Symlin was identified as the primary suspect. The most commonly reported side effects were blood glucose increased, nausea, and blood glucose decreased. We identified 150 hospitalizations and 13 deaths where Symlin was identified as the primary suspect.

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FDA Approves Suprax Capsules, 400 mg

June 5, 2012 By

On June 5, 2012, Lupin Ltd. announced that its subsidiary, Lupin Pharmaceuticals, Inc., received FDA approval for Suprax (cefixime) capsules 400 mg. The approval of the 400 mg tablets will expand the range of Suprax dosage forms available. Currently two oral suspensions (100 mg/5ml and 200 mg/5 ml) are available in addition to the 400 mg tablets.

Analysis:

Suprax is a cephalosporin antibiotic indicated for the treatment of the following infections caused by susceptible strains of certain bacteria: otitis media, pharyngitis/tonsillitis, acute bronchitis & acute exacerbations of chronic bronchitis, uncomplicated urinary tract infections, and uncomplicated gonorrhea. Suprax was first FDA approved on April 28, 1989, marketed by Lederle Laboratories (now Pfizer). Lupin launched the oral suspension form of Suprax in the U.S. in February 2004.

Using data from AERS, from 01/01/2004 to 12/31/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 472 patients who experienced a serious adverse event where Suprax was identified as a suspect drug causing the event and 120 patients who experienced a serious adverse event where Suprax was identified as the primary suspect. The most commonly reported side effects were pruritus, condition aggravated, and diarrhea. We identified 80 hospitalizations and 6 deaths where Suprax was identified as the primary suspect.

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Genentech Study Finds that Avastin Plus Chemotherapy Improves Survival in Patients with Colorectal Cancer

June 4, 2012 By

On June 2, 2012, Genentech, a member of the Roche Group, announced results from a Phase 3 study of Avastin (bevacizumab) in patients with metastatic colorectal cancer (mCRC). The study evaluated patients with continued Avastin treatment and second-line chemotherapy and patients treated with Avastin and first-line chemotherapy. First-line chemotherapy is initial chemotherapy and second-line chemotherapy refers to chemotherapy that begins after the cancer progresses.

The study found that the?relative risk of death was reduced in patient receiving continued Avastin and second-line chemotherapy compared to patients receiving chemotherapy alone. There was also an improvement in progression-free survival in patients treated with Avastin plus second-line chemotherapy.

Hal Barron M.D., chief medical officer and head, Global Product Development, said, “While conventional practice is to change treatment completely at disease progression, the continued use of Avastin with a new chemotherapy regimen in this study resulted in patients living longer, compared to a new chemotherapy regimen alone.”

Analysis:

Avastin is an injectable anti-cancer drug that blocks the growth of new blood vessels. It is a human monoclonal antibody, approved in the U.S. for the treatment of certain types of metastatic colorectal cancer (mCRC), advanced nonsquamous non-small cell lung cancer (NSCLC), metastatic kidney cancer (MRCC), and glioblastoma (GBM). It is approved as a first-line treatment or second-line treatment for colorectal cancer, but is not approved for both. Avastin was FDA approved on February 26, 2004 and is marketed by Genentech.

Using data from AERS, from 01/01/2004 to 12/31/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 21,080 patients who experienced a serious adverse event where Avastin was identified as a suspect drug causing the event and 14,248 patients who experienced a serious adverse event where Avastin was identified as the primary suspect.

The most commonly reported side effects were death, pyrexia (fever), diarrhea, disease progression, nausea, vomiting, dehydration, and hypertension. We identified 6,534 hospitalizations and 2,493 patient deaths where Avastin was identified as the primary suspect.

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Janssen Announces Result from Phase 3 Study of Zytiga

June 4, 2012 By

On June 2, 2012, Janssen Research & Development, LLC announced the results of a Phase 3 study of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with Zytiga (abiraterone acetate) plus prednisone. The study found that patients treated with Zytiga and prednisone exhibited an improvement in radiographic progression-free survival (rPFS) compared to patients treated with placebo and prednisone. In addition, there were significant improvements in median overall survival and secondary study endpoints for patients in the Zytiga group.

Johnson & Johnson?s press release stated that this study is the first to demonstrate an improvement in rPFS and overall survival in this patient population.

Analysis:

Zytiga is an oral CYP17 inhibitor indicated for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. Zytiga was FDA approved on April 18, 2011 and is marketed by Janssen Biotech, Inc., a Johnson & Johnson company.

In clinical trials, the most commonly reported adverse events were joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures, and upper respiratory tract infection.

Using data from AERS, from 01/01/2004 to 12/31/2011, aggregated and standardized by the AdverseEvent RxFilter process, we identified 405 total patients who experienced a serious adverse event where Zytiga was identified as a suspect drug causing the event and 324 patients who experienced a serious adverse event where Zytiga was identified as the primary suspect. The most commonly reported side effects were prostate specific antigen increased, anemia, and nausea. We identified 169 hospitalizations and 55 deaths where Zytiga was identified as the primary suspect.

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