Dive Brief:
- The Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) review by three months of Sanofi’s type II diabetes injection drug iGlarLixi, a fixed ratio combination of Adlyxin (lixisenatide) and Lantus (insulin glargine).The new PDUFA date is now in November.
- Sanofi said the delay occurred because it submitted new information about the drug’s pen-delivery device at the FDA’s request. This, in turn, resulted in a “major amendment” to the original New Drug Application (NDA), leading to the new review timeline. In May the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended by a vote of 12-2 to approve the NDA for iGlarLixi.
- As for the injectable’s two constituent drugs, the FDA last month approved Adlyxin, a glucagon-like peptide-1 (GLP-1) receptor agonist, while patent protection for Lantus expired in most countries last year.
Dive Insight:
While three months may be a relatively short amount of time in the life of a drug, when viewed through the prism of the diabetes market it could mean Sanofi loses its first-to-market advantage for the combination product.
Sanofi has been battling to save its diabetes franchise now that its blockbuster insulin Lantus has been facing increasing generic competition around the world and competitors are expected to bring biosimilar versions of the drug forward in the US shortly.
The French pharma has taken a number of steps to ensure that its combination insulin-GLP-1 product hit the market first and gain any advantage that it can. The company used a Priority Review Voucher that it purchased from Retrophin in 2015 for $245 million. The coupons are issued by the FDA when companies bring forward treatments for rare pediatric diseases. While the vouchers are meant to expedite those treatments, companies have been selling them -- for high price tags -- to other pharmas that are looking for a competitive advantage.
In this case, Sanofi is looking to beat rival Novo Nordisk to market. The Danish pharma has been developing its own combination insulin-GLP-1 product that combines its insulin Tresiba (degludec) with its market-leading GLP-1 Victoza (liraglutide). The product is already marketed as Xultophy in Europe and would be known as IDegLira in the US. An FDA Advisory Committee voted unanimously to approve the drug in May.
However, it could feel like a boost to its rivals, each of whom is racing to bite a bigger chunk out of a market that was worth $20 billion in 2010 and is expected to surge to $32 billion by next year — a compound annual growth rate of 7.5%.
For its part, the French drug maker said it “appreciates the feedback from the FDA on the delivery device and believes that the information submitted will result in an offering that will serve the needs of adults living with type 2 diabetes in the US.”
Sanofi owns the rights to market Adlyxin in the US from Zealand Pharma A/S while outside the US it markets the injection as Lyxumia.