Merck’s follow-on biologic Lusdana Nexvue gets tentative FDA approval

SILVER SPRING, Md. — The Food and Drug Administration has given tentative approval to Merck’s follow-on biologic basal insulin Lusdana Nexvue (insulin glargine injection), the company announced Thursday. The tentative approval notes that the drug has met the required regulatory standards, but is subject to an automatic stay, as Sanofi has claimed patent infringement on its insulin product Lantus.

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

Under the Hatch-Waxman Act, Sanofi’s lawsuit, filed in September 2016, automatically invoked a stay on Lusdana Nexvue up to 20 months, or in the event the court finds in favor of Merck — whichever occurs first.

In 2016, Lantus was among the top 20 drugs by sales, according to QuintilesIMS, with an invoice-based spending total $3.3 billion.