FDA Advisory Committee Recommends Approval of Sanofi’s Nasacort AQ Nasal Spray for Over-the-Counter Use

Sanofi has announced that 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 US.

  
“Today’s (31 July 2013) 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 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 FDA in its review of the Supplemental New Drug Application (sNDA) for Nasacort AQ as an OTC treatment. 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.