Tentative US approval for Merck’s diabetes therapy

The US Food and Drug Administration has given a tentative green light to Merck & Co’s follow-on biologic basal insulin Lusduna Nexvue. The decision means that the drug has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, but is subject to an automatic stay due to a lawsuit from Sanofi claiming that it infringes on patents for its diabetes therapy Lantus (insulin glargine). As per the Hatch-Waxman Act, Sanofi’s lawsuit, which was filed in September 2016 alleging infringement of 10 patents, prevents a final approval from the FDA on Lusduna Nexvue for either 30 months or in the event a court finds in favour of Merck, whichever comes sooner.