Merck eyes US approval with positive data on Lantus copy
- Merck's investigational biosimilar version of Sanofi's Lantus (insulin glargine) met its primary and secondary endpoints in two Phase 3 studies, the company said Monday. The results set up an application to the FDA for U.S. approval.
- In both trials, the drug, known as MK-1293, demonstrated non-inferiority to Lantus in reducing average blood glucose, while also showing equivalence. The studies looked at patients with both type 1 and type 2 diabetes.
- Under a 2013 agreement with Samsung Bioepis, Merck is responsible for the clinical development, manufacturing, and commercialization on MK-1293. Samsung Bioepis will partial fund its development.
While MK-1293 is considered a biosimilar in other regulatory jurisdictions, Merck is submitting the drug as a "follow-on biologic" in the U.S. The FDA recently approved Eli Lilly's Lantus copy Basaglar under the same designation.
Merck's prowess in the diabetes market is based on the strength of its Januvia franchise, which is currently worth more than $6 billion per year. However, this would be Merck's first insulin product on the market.
Merck demonstrated appropriate efficacy and safety, including immunogenicity testing. MK-1293 has the same amino acid structure as Lantus and a similar profile in terms of side effects, specifically hypoglycemia. In clinical trials, 52.1% and 53.2% of Lantus-treated and MK-1293-treated patients, respectively, experienced symptomatic hypoglycemia.
“The investigational agent MK-1293 represents Merck’s entry into insulin therapeutics and into treatments that may be useful for patients with type 1 diabetes, and we are pleased with these Phase 3 results,” said Peter Stein, vice president of late stage development for diabetes and endocrinology at Merck.