Pharmaceutical giant Merck has been granted tentative approval for Lusduna Nexvue (insulin glargine injection) 100 units/mL by the US Food and Drug Administration.
The follow-on biologic basal insulin comes in a pre-filled dosing device and will be used to treat patients with type 2 diabetes. It will be marketed under the name Lusduna Nexvue, following Merck's announcement that the firm had gained temporary approval for the name should the product be launched.
Merck's latest drug satisfied the regulatory requirements related to efficacy, safety and quality regarding follow-on biologics. However, the product is subjected to an automatic stay due to a patent infringement lawsuit brought by Sanofi in 2016. Consequently, there will be a stay on final approval for Merck's product for up to 30 months, or until a court rules in Merck's favor.
Sanofi alleges the new diabetes drug infringes on 10 patents for its own insulin glargine injection Lantus, a basal insulin approved for use once each day. The medication may be administered with the Lantus SoloSTAR Pen, or alternatively patients may inject using a vial and syringe.
Sam Engel, MD, associate vice president of Merck clinical research, diabetes, endocrinology and women's health, described the FDA's tentative approval of Lusduna Nexvue as an "important milestone". He added it brings the company "closer to offering this medicine to patients".
Other insulin pens available in the US include Eli Lilly's HumaPen Luxura HD and Humalog KwikPen U-100, and the NovoPen Echo made by Novo Nordisk. Earlier this month, Novo Nordisk recalled six batches of the NovoPen Echo due to a weakness in the insulin cartridge holders, which made them susceptible to cracking or breakage when exposed to certain chemicals.