FDA Grants Tentative Approval to Biologic Insulin

Merck recently announced that the FDA granted tentative approval to Lusduna Nexvue (insulin glargine injection) 100 units/mL. The drug is a follow-on biologic basal insulin for patients with type 2 diabetes and is administered through a pre-filled dosing device, according to a press release.

Lusduna Nexvue met all regulatory requirements for follow-on biologics related to safety, efficacy, and quality; however, due to the tentative approval, it is subjected to an automatic stay as the result of a patent infringement lawsuit brought by Sanofi.

In the lawsuit, Sanofi alleges that Merck’s follow-on biologic infringes upon 10 patents for their insulin glargine injection (Lantus). Under the Hatch-Waxman Act, the 2016 lawsuit invoked a stay on the final approval of the drug for up to 30 months or if the court rules in favor of Merk, according to the release.

Merck reported that the name Lusduna Nexvue was also granted temporary approval and will be used if the product is launched.

“The tentative approval of Lusduna Nexvue is an important milestone, bringing us closer to offering this medicine to patients,” said Sam Engel, MD, associate vice president, Merck clinical research, diabetes, endocrinology and women’s health.