Hanmi Pharm's diabetes drug proven effective in large-scale clinical trial

[Source: Hanmi Pharmaceutical Co.]

Hanmi Pharmaceutical said on Tuesday its investigational diabetes drug efpeglenatide has been shown to significantly reduce the risk of adverse cardiovascular and renal events among type 2 diabetics in a large-scale global study involving over 4,000 patients.

Sanofi, an ex-marketing right holder of the glucagon-like peptide-1 (GLP-1) receptor, presented data from a Phase 3 clinical trial (AMPLITUDE-O) at the American Diabetes Association (ADA) scientific session.

Participants at 344 centers in 28 countries were randomly assigned to receive weekly subcutaneous injections of efpeglenatide at a dose of 4 or 6 mg or placebo.

According to Sanofi’s announcement, efpeglenatide reduced the risk of major adverse cardiovascular events by 27 percent and renal disease by 32 percent compared to placebo. These statistically significant results were published in the New England Journal of Medicine.

Sanofi had conducted Phase 3 clinical trials for the novel drug in-licensed from Hanmi Pharmaceutical in 2015. But in 2020, Sanofi informed Hanmi Pharmaceutical of its intention to return all rights on the drug due to its change in business strategy.

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