FDA approves long-acting insulin analogue for type 1 and type 2 diabetes

The U.S. Food and Drug Administration has approved Semglee (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes.

“This approval is an important milestone, first and foremost for the millions of patients living with diabetes in the U.S. as we seek to expand their access to insulin through more affordable treatment options,” said Heather Bresch, CEO of Mylan, in a press release. “It’s also another milestone for Mylan as we continue to leverage our scientific, commercial, manufacturing and regulatory expertise to benefit patients, and as we enhance our portfolio with increasingly complex and higher value-chain products, like insulin. Leveraging these capabilities, whether through our internal teams or through strong partnerships like the one we’ve built with Biocon, strengthens our ability to deliver innovative solutions to patients in the U.S. and around the world.”

Read the full press release here.