Sanofi Announces FDA Panel Recommends Approval of Nasacort Spray

Sanofi

announced today that the U.S. Food and Drug Administration's (FDA) Nonprescription Drugs Advisory Committee (NDAC) voted 10 to 6, with 2 abstentions, recommending approval of Nasacort® AQ Nasal Spray (triamcinolone acetonide) for over-the-counter use in the U.S. "Today's positive NDAC vote was an important step forward in providing broader access to Nasacort AQ for nasal allergy sufferers," said Charles Hugh-Jones, MD, MRCP, Chief Medical Officer, Sanofi US. "We appreciate the feedback from the Committee and look forward to working with FDA in completing its review." If approved by the FDA, Nasacort AQ would be first-in-class as an OTC medicine and marketed by Sanofi's consumer healthcare division, Chattem, Inc. The proposed OTC indication is temporary relief of nasal symptoms of hay fever or other upper respiratory allergies (allergic rhinitis) in adults and children 2 years of age and older. "The OTC availability of Nasacort would continue to build on Chattem's highly successful OTC launch of Allegra and further expand our consumer healthcare offering," said Anne Whitaker, President, North America Pharmaceuticals, Sanofi. Among prescription and OTC allergy products, Nasacort AQ and other nasal sprays in the same medication class are considered the most effective treatment for hay fever and other upper respiratory allergies. The NDAC panel's recommendation will be considered by the FDA in its review of the Supplemental New Drug Application (sNDA) for Nasacort AQ as an OTC treatment. The FDA's decision will also be based on data submitted from 13 placebo-controlled efficacy studies, and safety information from 43 clinical studies, as well as information from 16 years of post-marketing surveillance data. Prescription Indication Nasacort AQ Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older.