New diabetes drug set to rival Trulicity

If it is approved by FDA, an investigational drug to improve glycemic control in patients with type 2 diabetes will likely be a strong competitor to Eli Lilly’s dulaglutide (Trulicity).

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Semaglutide (Novo Nordisk) is one step closer to FDA approval, after the agency’s Endocrinologic and Metabolic Drugs Advisory Committee voted 16 to 0 in support of approving the drug.

Semaglutide, a long-acting glucon-like peptide-1 (GLP-1) analogue, has the potential to be a blockbuster drug and offer stiff competition to Trulicity, which is expected to produce sales of  $3.71 billion by 2023, according to Thomson Reuters data, Reutersreported.

“Semaglutide has the potential to impact the lives of people with type 2 diabetes by helping to meaningfully reduce A1c. This treatment option may also help people lose weight,” said Todd Hobbs, vice president and US chief medical officer of Novo Nordisk, in a statement from Novo Nordisk. “We look forward to continuing to work with the FDA as they complete their review of semaglutide.”

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FDA Committee’s recommendation for approval was based on data from the global SUSTAIN phase 3a clinical trial program, which evaluated the safety and efficacy of semaglutide, administered once-weekly. The trials involved more than 8,000 adults with type 2 diabetes, including adults with high cardiovascular risk profiles, with and without renal disease.

However, the committee members also discussed data showing that semaglutide was associated with an initial worsening of diabetic retinopathy, a condition caused by damage to blood vessels in the retina due to high blood sugar levels. “But they found that the benefit of reducing blood sugar overall offset this risk, which the company argues is transient,” Reuters wrote.

“The drug has also been shown to reduce cardiovascular risks, although it was unclear whether the FDA will include that in the label,” Reuters wrote.

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