Sanofi has amended its new drug application (NDA) for the diabetes therapy combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide by submitting updated information about the therapy's pen delivery device. The additional information, submitted at the request of the Food and Drug Administration (FDA), constitutes a major amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act (PDUFA) goal date by three months to November 2016.

On May 25, 2016, the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA recommended the approval of the NDA for the fixed-ratio combination for treatment of Type 2 diabetes.

Diabetes is Sanofi’s most important therapeutic franchise from a revenue perspective, accounting for 2015 revenues of EUR 7.58 billion ($8.48 billion). The combination therapy is important for Sanofi as it faces generic competition for Lantus (insulin glargine), its top-selling product in 2015 with sales of EUR 6.39 billion ($7.22 billion).

In 2015, Retrophin, a San Diego, California-based biopharmaceutical company, sold a rare pediatric disease priority review voucher (PRV) to Sanofi for $245 million, which Sanofi later applied in its NDA for the fixed combination product to gain priority review of the product by the FDA

The FDA voucher program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. A voucher may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single new drug application or biologics license application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the voucher upon approval of the rare pediatric disease product application and the voucher may be transferred to another company.

Retrophin received the voucher following the March 2015 approval of Asklepion Pharmaceuticals’ drug Cholbam (cholic acid), a drug to treat pediatric and adult patients bile acid synthesis disorders. Asklepion transferred the PRV to Retrophin, which had licensed the rights to the voucher under an earlier agreement. Sanofi purchased the PRV from Retrophin in July 2015 and redeemed it in its NDA for the fixed combination product in December 2015 to gain a priority review of the product of six months rather than standard review period of 10 months by the FDA.

Source: Sanofi