Merck's Lantus follow-on gets tentative thumb's up
- The Food and Drug Administration has granted Merck & Co. tentative approval for Lusduna Nexvue, a follow-on version of Sanofi's Lantus (insulin glargine). Merck developed the drug with funding from Samsung Bioepis.
- The initiation of a lawsuit by Sanofi in September 2016 has slapped an automatic 30-month stay on final FDA approval under the Hatch-Waxman Act.
- Lusduna Nexvue is the second Lantus follow-on to have received approval in the U.S. behind Eli Lilly & Co.'s Basaglar, which got the go-ahead in December 2015.
The good news for Merck is that it gets tentative approval for Lusduna Nexvue, its Lantus (insulin glargine) follow-on; the bad news is that it still has to wait 30 months for full and final approval from the Food and Drug Administration, unless a court finds in favor of Merck before then.
While Merck has met all regulatory standards for the drug, a lawsuit filed by Sanofi last year that alleges patent infringement will keep the drug off the market for more than two years.
While this could take time to be a revenue-driver for Merck, it is another nail in the Lantus coffin for Sanofi. The French drugmaker has been flailing and may be moving away from diabetes altogether to pursue its burgeoning immunology franchise.
Lilly's Basaglar was the first approved follow-on insulin glargine, in December 2015. It finally hit the U.S. market in December 2016. The first quarter 2017 sales were $46 million, compared with $10.9 million the previous year, a 321% increase. The launch of Basaglar has already made a dent in Lantus' already slipping sales, albeit a small dent at this point.
Lantus' 2016 sales were €5.7 billion ($6.6 billion), a 9.4% fall on the previous year. However, the first quarter 2017 sales, post-Basaglar launch, were €1.2 billion ($1.4 billion), a fall of 14.1% on the previous year. And the pharmacy benefit managers CVS Health and United Health announced last year that they would replace Lantus with Basaglar in the 2017 formulary lists.
Toujeo, Sanofi's own Lantus follow-on, was approved by the FDA in February 2015, and its sales continue to climb, with first quarter 2017 sales of €192 million ($223 million), up 78.6% on the previous year. This, however, isn't really filling the dent left by Lantus for Sanofi.
Indian company Biocon, with its partner Fujifilm Pharma, has launched an insulin glargine in Japan. This is also available in India as Basalog, and approval in more than 20 countries. Biocon is working with Mylan for approvals in developed countries outside Japan.
- Merck & Co. Approval Statement
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