FDA Approves Lilly's Copycat of Lantus

It took awhile, but the end of patent protection for Lantus finally means competition Sanofi’s mainstay long-acting insulin glargine, as the FDA approved Basaglar, an identical amino acid sequence delivered with a prefilled pen.

Things didn’t come easy for Eli Lilly and Boehringer Ingelheim; Sanofi sued for patent infringement, and Lilly had to reach a settlement before the approval could move forward. Basalgar has been approved in 10 other countries. Per the settlement, Basalgar will not launch until December 15, 2016.

FDA approved Basalgar to control high blood sugar in adults and children with type 1 diabetes and adults with type 2 diabetes, according to a statement from the Lilly. “Lilly has a long history of developing and manufacturing insulin, having introduced the world’s first commercial insulin more than 90 years ago,” said David Kendall, MD, vice president for Global Medical Affairs for Lilly.

Sanofi, meanwhile, is marketing Toujeo, its next generation long-acting insulin, which clinical trials show may be more forgiving for patients who are not as prompt about injecting themselves at precise 24-hour intervals.

FDA lifts rosiglitazone REMS. The FDA has formally lifted all remaining restrictions on rosiglitazone, the one-time blockbuster diabetes drug sold as Avandia, whose saga forever changed the approval process for diabetes and cardiovascular therapies.

In 2013, the agency ended most restrictions on the drug more than 2 years after it had imposed special requirements for patients to obtain the drug. That came after an article in the New England Journal of Medicine linked the drug to increased risk of heart attacks. Yesterday, the risk evaluation and mitigation strategy (REMS) ended completely.

As a result of the uproar over rosiglitazone, FDA now requires long-term cardiovascular outcomes trials to catch any possible risk of heart attack or stroke caused by newer therapies; FDA also looks for risks of certain cancers, especially pancreatic. Results of these trials are eagerly awaited, as any CV advantage of 1 drug in a particular class would possibly give it a leg up on a formulary over another.

The effect on the scientific process for approving new therapies is the legacy of rosiglitazone; FDA's action will likely have little practice effect because so few patients still take the drug, according to physicians who commented yesterday.