Roche, Biogen Idec Scrap Development of Arthritis Drug: Biotech's Latest Mishaps
The Burrill Report submits: Roche (RHHBY.PK) and Biogen Idec (BIIB) say they will discontinue development of late-stage ocrelizumab in rheumatoid arthritis. The decision follows an analysis of the efficacy and safety results from the program that led the companies to conclude the antibody carried too great a risk to rheumatoid arthritis patients compared to benefits and available treatment options. The ocrelizumab rheumatoid arthritis program included four late-stage studies. Ocrelizumab is also being evaluated for relapsing remitting multiple sclerosis in a mid-stage trial. In March, Roche and Biogen Idec announced the suspension of treatment in the ocrelizumab rheumatoid arthritis program. This decision followed a recommendation from the independent ocrelizumab RA & Lupus Data and Safety Monitoring Board. The data safety monitoring board concluded that the safety risk outweighed the benefits observed in these specific patient populations at that time based on an infection related safety signal that included serious infections, some of which were fatal, and opportunistic infections. Subsequently, the U.S. Food and Drug Administration placed the rheumatoid arthritis studies on clinical hold. Teva Pharmaceutical Industries (TEVA) said its experimental to treat Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig’s disease, failed in a mid-stage trial. The trial was designed to assess efficacy, safety and tolerability of Talampanel (a selective AMPA antagonist) in reducing disease-related functional deterioration in ALS patients. Teva said the trial showed Talampanel was safe for ALS patients, but the study did not meet its primary endpoint. Complete Story »
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