Watson’s Rapaflo Sails Through FDA: The Exception That Proves The Rule?

Analysts don’t expect much from Watson’s Rapaflo, a new entrant in the already crowded alpha-blocker benign prostatic hyperplasia category.

But if the drug is any where as good as relieving obstructed bladders as it was at breaking through the bottleneck at FDA, don’t bet against it.

Let’s recap what we know about today’s FDA. The agency doesn’t have the resources to review applications on time. (See “Talent Squeeze at FDA,” The RPM Report, December 2007.) It also has the strategic good sense to realize that now is not the time to make on-time approvals the top priority. (See “The New User Fee Rules,” The RPM Report, March 2008.)

There’s more. “Standard” review applications will receive at least one “complete response” letter before approval—if they are approved at all. (See “The Data Everyone’s Talking About,” The RPM Report, November 2007.) Inexperienced NDA filers shouldn’t kid themselves into believing they will even get a review by FDA. (See “Rejected Out of Hand,” The RPM Report, February 2008.) And products for crowded primary care indications can only come to market in the US if they have been sold forever overseas (See “When Approvable is Good News,” The RPM Report, December 2007) or if they have clear evidence of comparative advantages over existing therapy. (See “Straight Talk From FDA,” The RPM Report, November 2007.)

So, if you had asked us about Watson’s chances on Rapaflo, filed in December under a licensing agreement with Kissei, we’d have bet all our US Treasury bonds that they’d have at least another year to wait before getting the all clear from FDA.

Good thing you didn’t ask. As “The Pink Sheet” reports, Rapaflo received approval from FDA on Oct. 9—three days before the 10-month standard review deadline.

So here’s a drug entering a huge primary care market (we found one estimate that there are 115 million men worldwide with BPH) approved based on clinical trials in less than 1,000 patients. It has only minimal global market experience (two years in Japan). The sponsor—Watson—is still far better known for its generic drug applications than its new drug savvy, and there are already four brands available in the same class for the same indication.

Can this be the same FDA that just imposed a formal risk evaluation and mitigation strategy on a drug that isn’t even marketed anymore? (It is—FDA is requiring a REMS for Exubera.)

Maybe FDA read the analyst reports, which suggest Watson will have at best modest success (say $50 million a year) selling Rapaflo in a generic-first class. But we doubt it. This is definitely a clear sign that the old model FDA is completely dead yet. Product by product, division by division, there are still openings for these kind of approvals.

Though we still wouldn’t build our business on expecting too many more Rapaflo’s in the years to come…