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FDA panel backs OTC use of Sanofi's allergy drug

Says Nasacort AQ can be sold without prescription

Sanofi reception

Sanofi is on course to win US approval for the over-the-counter (OTC) use of its allergy drug Nasacort AQ.

An advisory panel to the US Food and Drug Administration (FDA) voted 10 to six in favour of the indication, which would allow patients to buy Nasacort AQ (triamcinolone) without a prescription.

If given final approval by the FDA, the nasal spray would be the first medicine of its kind available as on OTC product.

It would be marketed by Sanofi's consumer healthcare division Chattem, which Sanofi acquired for just under $2bn in 2009.

“Today's positive Nonprescription Drugs Advisory Committee vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers,” said Charles Hugh-Jones, chief medical officer, Sanofi US.

Nasacort AQ has been available as a prescription medicine for temporary relief of the symptoms of respiratory allergies for some time, making $375m at peak annual revenues.

Profits have declined since 2008, however, when Teva and Barr Pharmaceuticals won a patient challenge to launch their own generic copy, and Nasacort AQ achieved revenues of just €71m during 2012 for Sanofi.

The company will be hoping an OTC indication in the US will give it some advantage over the generic competition and boost sales.

This is part of a wider plan to build its consumer healthcare business, which CEO Chris Viehbacher discussed in the company's financial results for the second quarter of 2012.

Sanofi has already won OTC approval for another allergy drug, with Allegra (fexofenadine) backed by the FDA for non-prescription use in 2011 following the loss of patent exclusivity.

Allegra made €164m in the first half of 2013, becoming Sanofi's biggest selling consumer healthcare product, while prescription sales of the drug in the same period were down 6.8 per cent on 2012, coming in at €248m.

2nd August 2013

From: Sales



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