Sanofi's ($SNY) list of OTC offerings may soon be getting a little bit longer. An FDA advisory committee has recommended approval of Nasacort AQ Nasal Spray for over-the-counter use, the company announced Thursday.
The positive vote from the agency's Nonprescription Drugs Advisory Committee (NDAC) positions the allergy medicine, which treats hay fever and upper respiratory allergies, to be first in its class as an OTC medicine if approved by the FDA. "Today's positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers," Sanofi U.S.'s Chief Medical Officer Charles Hugh-Jones said in a statement. The FDA will now weigh the recommendation, as well as study data and safety information, in order to make its decision.
The OTC go-ahead would also bolster Sanofi's Chattem consumer healthcare division, which the French drugmaker began expanding in advance of the patent cliff. Chattem already has experience launching Allegra as an over-the-counter product, which it did in 2011. And while OTC Nasacort won't touch Allegra's sales levels, it's still a revenue opportunity. Prescription Allegra sales in 2011 amounted to €580 million, and the OTC version churned out €211 million ($280 million). Nasacort, with peak sales of $375 million, brought in €71 million (about $94 million) last year; even a piece of that in OTC revenue would benefit Sanofi, which Thursday reported a 9.8% decline in Q2 net sales that shocked analysts.
The thumbs up from the advisory committee also granted some insight into the approval likelihood for other Big Pharma firms hoping to convert their big-selling prescription drugs. The regulatory body hasn't always been so open to doling out OTC status in the past, but these days, it appears to be more amenable to the idea--a shift that would expand consumer access and save money for government programs currently paying prescription prices.
- see the release
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