FDA to review new combination diabetes drugs

diabetes illus250x03 FDA to review new combination diabetes drugsFrench drugmaker Sanofi plans to redeem a fast-track voucher to gain accelerated regulatory review of its experimental combination diabetes drug Lixilan, a once-daily injectable treatment that combines its blockbuster insulin Lantus with Lyxumia, a Type 2 diabetes medication currently marketed in Europe.

Lyxumia is not yet approved in the United States but is currently under review by the Food and Drug Administration (FDA). It is in a class of type 2 diabetes drugs known as GLP 1 receptor agonists. Other drugs in this class include the brand names Byetta and Victoza.

Sanofi hopes to give Lixilan the edge over competitor Novo Nordisk, maker of Victoza. Novo has filed a new drug application for its experimental diabetes drug Xultophy, a combination of its insulin drug Tresiba and Victoza.

Sanofi holds a prior review voucher, which it purchased from Asklepion Pharmaceuticals for $245 million. The voucher will reduce the review period from 10 months to six.

FDA regulators will have to weigh the benefits of the both Sanofi and Novo Nordisk’s combination drugs. GLP-1 receptor agonists have been linked to serious side effects including a painful inflammation of the pancreas known as acute pancreatitis. The drugs have also raised concerns regarding cancer risks. Both Byetta and Victoza have been linked to pancreatic cancer and thyroid cancer.

An estimated 29 million people in the United States have Type 2 diabetes and the number is expected to grow in step with the American obesity epidemic. Drugmakers are working hard to bring new treatments to the market, generating billions in annual sales.

Source: Modern Healthcare