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.
Fool contributor Brian Orelli holds no position in any company mentioned. Click here to see his holdings and a short bio. Motley Fool newsletter services have recommended buying shares of Vertex Pharmaceuticals. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
More from The Motley Fool
Will This Drug Kick-Start Regeneron Pharmaceuticals Shares?
An immuno-oncology drug that's in the works could generate significant revenue growth someday.
This Double Whammy Caused Regeneron Pharmaceuticals Inc. to Fall 10% in November
Shareholders aren't seeing too clearly after this double-dose of news concerning lead drug Eylea.
Here's Why Regeneron Pharmaceuticals Inc. Slipped 10% in October
Tiny start-up AnaptysBio helped spread fear that Dupixent's ongoing commercial launch might fizzle out.