In a 10-5 decision, an FDA expert panel voted against approval Daxas, Forest Laboratories and Nycomed's drug for chronic obstructive pulmonary disorder (COPD). The panel did vote 9-6 that the drug is safe and effective. "The benefit of this drug, although it's there, it's meager," noted one panelist. That benefit obviously wasn't enough to warrant the panel's backing, as many thought the side effects of Daxas outweighed the limited improvement in lung function. An FDA decision is due in May, and although the agency doesn't have to follow the panel's recommendations, it generally does.
Forest could gain approval of the the drug for a narrower group of patients, rather than the broad COPD indication. "We believe there is still room for us to begin and go forward with negotiations with the agency," said Forest President and COO Lawrence Olanoff.
Nycomed, which developed the drug, conducted four Phase III trials of Daxas and got a $100 million upfront payment from Forest for the licensing deal last year. The company stood to gain an additional $500 million in milestones for the drug, which has blockbuster potential if it can compete with GSK's mega-seller Advair.
- here's the Reuters article