Talk about a rubber stamp. The Food and Drug Administration advisory panel voted 10-0 on Friday, recommending approval of Regeneron Pharmaceuticals'
The biggest issue the panel seemed to have was over the potential cost of the drug, but that's not going to factor into the FDA's decision over whether to approve the macular degeneration treatment.
The panel of outside experts even finished evaluating Eylea quick enough that the stock resumed trading Friday afternoon. That didn't happen with recent committee meetings for drugs from Optimer Pharmaceuticals
This is the part of the article where I'd usually mention that the FDA isn't required to follow the panel's advice. But that doesn't seem all that necessary, does it? In the briefing documents prepared for the panel members, the FDA reviewers appeared pretty happy with the data package Regeneron produced. Add in a unanimous advisory panel endorsement, and there doesn't seem to be any reason to suspect the FDA will have a problem with Eylea's efficacy and side effect profile.
About the only thing I could possibly see tripping up Regeneron now is some sort of manufacturing issue. But the risk that the biotech might miss something the FDA wants in an approved product is somewhat muted by the fact that Regeneron already has one drug on the market.
FDA approvals are never a rubber-stamp affair. But Regeneron's chance of seeing an FDA approval on or before its Aug. 20 PDUFA date seems highly likely at this point.
Interested in keeping track of Regeneron as it gets its decision back from the FDA? Click here to add it to My Watchlist, which will help you keep track of all our Foolish analysis on Regeneron.
