Merck & Co. granted tentative FDA approval for diabetes therapy Lusduna Nexvue

Merck & Co. on Thursday announced that it received tentative approval from the FDA for Lusduna Nexvue (insulin glargine), a follow-on biologic basal insulin in a pre-filled dosing device. Merck associate vice president of clinical research, diabetes, endocrinology and women’s health Sam Engel remarked "the tentative approval of Lusduna Nexvue is an important milestone, bringing us closer to offering this medicine to patients."

Merck explained that while Lusduna Nexvue has achieved all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, final FDA approval has been delayed due to a patent infringement lawsuit filed by Sanofi in September last year related to the latter's insulin glargine products Lantus and Lantus SoloSTAR. The drugmaker added that the litigation triggered a stay on final approval for up to 30 months or in the event a court rules in Merck's favour, whichever occurs sooner. 

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Tentative approval of Lusduna Nexvue, which came via the FDA's 505(b)(2) regulatory pathway, follows final clearance of Eli Lilly's insulin glargine product Basaglar in 2015. Final authorisation of the therapy, which amassed $86.1 million in revenue last year, was granted after the company reached a settlement with Sanofi regarding the latter's patent infringement lawsuit.

Sales of Lantus in 2016 exceeded 5.7 billion euros ($6.6 billion), representing more than one-sixth of Sanofi's revenue last year. Meanwhile, CVS Health removed the drug from its standard 2017 formulary due to the availability of biosimilar alternatives.

Lusduna Nexvue, formerly known as MK-1293, was developed by Merck with funding from Samsung Bioepis, a joint venture between Samsung BioLogics and Biogen. 

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