FDA review panels give nod to two drugs, votes on third today
On Tuesday, the Arthritis Advisory Committee unanimously recommended approval of Bristol-Myers Squibbs' Orencia (abatacept), aimed at rheumatoid arthritis.
Reviewers said abatacept's benefits outweighed its risks, which include a slightly higher infection rate among users in clinical trials, as well as some types of cancer.
Pfizer also received good news after the Endocrinologic & Metabolic Drugs Advisory Committee voted 7-2 yesterday in favor of approving Exubera, an inhaled insulin being developing with Sanofi-Aventis and Nektar Therapeutics.
The panel supported the drug's use in Type 1 and Type 2 diabetes, despite concerns about potential adverse lung effects.
That same committee meets today to consider Pargluva (muraglitazar), a BMS and Merck drug for Type 2 diabetes. According to a pre-meeting brief, overall muraglitazar therapy was well tolerated, but some patients showed elevated heart failure rates compared to those on an older drug.
Analyst forecasts for each of the three drugs have exceeded $1 billion in annual sales.