MacroGenics and Eli Lilly said teplizumab, an experimental monoclonal antibody for the treatment of type 1 diabetes, failed in a late-stage clinical trial. The Data Monitoring Committee, composed of independent experts in the fields of diabetes and biostatistics, completed a planned analysis of one-year safety and efficacy data of the trial of teplizumab. It concluded that the primary efficacy endpoint of the study, a composite of a patient's total daily insulin usage and HbA1c level at 12 months, was not met. No unanticipated safety issues were identified in the review. Based on the recommendation of the committee, the companies said they have decided to suspend further enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in type 1 diabetes.
The U.S. Food and Drug Administration rejected Bydureon, Amylin’s (AMLN) once-weekly diabetes treatment, citing safety concerns regarding the drug’s cardiovascular impact, an issue it had not previously raised. The agency also requested the results of a study that compared the drug to Byetta, a twice-daily injection that contains the same active ingredient as Bydureon. Amylin, Lilly, and their development partner Alkermes (ALKS) hope to submit their reply to the FDA’s request by the end of 2011, pending discussions with the agency.
Pfizer (PFE) is scrapping its plans for a late-stage clinical trial of its antipsychotic drug Geodon in children with bipolar disorder, Dow Jones reported. The company still plans to seek pediatric bipolar approval of the drug. The move follows last year’s decision by the FDA to request additional information before granting approval. Geodon already is marketed to treat schizophrenia and bipolar disorder in adults and has sales of $1 billion. In April, the FDA warned Pfizer of “significant violations” involving pediatric trials of the drug after inspectors discovered investigators in the trial were inadequately monitored by Pfizer and there was “widespread overdosing” of participants.
Eli Lilly said it will close its Singapore Center for Drug Discovery in December as part of wider review of its global business, Dow Jones reported. About 130 employees are expected to be affected by the closure. The company told the news organization it will transfer important projects and capabilities to the company's global headquarters.
A study published in the Journal of the American Medical Association found that Pfizer’s Prempro, a widely-used hormone therapy for women with menopause, increased the risk of death from breast cancer, Bloomberg reported. The analysis is the first to show the increase in breast cancer rates also led to more deaths. Researchers tracked 12,788 volunteers enrolled in the Women’s Health Initiative for 11 years. They found women taking Prempro were almost twice as likely to die from breast cancer as those on a placebo. The study in 2002 originally linked the use of the hormones to breast cancer and heart disease, which led to many women to discontinue use of the therapy.
Cardiome Pharma (CRME) said that its co-development partner, Astellas Pharma US (OTCPK:ALPMF), has suspended patient enrollment in a study of its experimental drug Kynapid as a treatment for certain types of atrial fibrillation. The decision followed a single, unexpected serious adverse event of cardiogenic shock experienced by a patient with atrial fibrillation who received the drug. The trial's independent Data Safety Monitoring Board has reviewed the case and recommended the trial continue, however the U.S. Food and Drug Administration has requested that full data regarding this case from the South American clinical site be provided for their review prior to determining what steps, if any, are needed to restart the study.
The U.S. Food and Drug Administration asked manufacturers to add new warnings to the labels of a class of drugs known as gonadotropin-releasing hormone agonists, which are primarily used to treat men with prostate cancer. The warnings would alert patients and healthcare professionals to the potential risk of heart disease and diabetes in men treated with these medications. In May, the FDA said that a preliminary and ongoing analysis found that patients receiving GnRH agonists were at a small increased risk for diabetes, heart attack, stroke, and sudden death. The new labels will include updates in the Warnings and Precautions section about these potential risks.