French drugmaker Sanofi is looking to once again beat a rival to the market by redeeming a voucher to fast track regulatory review, this time for its experimental combination diabetes drug Lixilan.
The company announced Wednesday it had submitted a new drug application to the U.S. Food and Drug Administration seeking approval of its investigational Type 2 diabetes treatment, a once-daily injectable treatment that combines of its blockbuster insulin drug Lantus with Lyxumia, a Type 2 diabetes medication approved in Europe that belongs to a class of drugs known as GLP-1 receptor agonists.
Sanofi is trying to gain approval ahead of competitor Novo Nordisk, which filed a new drug application in September for its experimental diabetes medication Xultophy, a combination of its insulin medicine Tresiba and its blockbuster GLP-1 agonist Victoza.
But Sanofi has the benefit of holding a priority review voucher, which it purchased from Baltimore-based Asklepion Pharmaceuticals for $245 million in May. Sanofi redeemed the voucher to shorten the review time to six months from 10.
It's a move the company has used before. In 2014 Sanofi and partner Regeneron bought a voucher from California-based BioMarin Pharmaceutical for $67 million. The companies then redeemed the voucher in order to fast-track review of its cholesterol-lowering drug Praluent, which won FDA approval a month ahead of rival Amgen's medication Repatha.
The FDA grants a voucher as a reward when a company develops and gets approval for a treatment of one of 17 tropical diseases or develops a therapy for a rare pediatric condition that affects more than 50% of those under the age of 18 and has fewer than 200,000 U.S. cases.
A voucher holder can either redeem it to expedite review of one of its other drugs or turn around and sell it to another company, which has created a secondary market that can yield hundreds of millions of dollars for the seller.
That aspect of the program was criticized recently when former KaloBios and Turing CEO Martin Shkreli announced that KaloBios had purchased the rights to sell a drug for Chagas disease in order to seek a review voucher despite the fact that the drug was not developed by his company and had been in use for years in other countries.
