Novo's experimental diabetes drug likely to compete with Trulicity
An FDA advisory committee is set to vote Wednesday on whether to recommend Novo Nordisk's experimental type 2 diabetes drug semaglutide for approval.
If approved, the drug would likely bring significant competition to the GLP-1 space, particularly for Eli Lilly's Trulicity. GLP-1's are often prescribed along with insulin to help patients with type 2 diabetes stabilize their blood sugar levels.
The FDA is not mandated to follow the committee's vote, but often does.
Ahead of the meeting, the FDA said in briefing documents that the drug is effective. Agency researchers wrote that the submitted data supported the claim that semaglutide could help improve blood-sugar control in patients with type 2 diabetes.
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If approved, semaglutide would set up a tête-à-tête with Eli Lilly's Trulicity, also a GLP-1 agonist. Trulicity, approved in 2014, was Lilly's best-selling new drug in 2016, bringing in $337 million. In the second quarter, Trulicity generated half, or $500 million, of Eli Lilly's total new product revenue. New product revenue accounted for 18% of global sales for Lilly in the same three-month period.
An online survey conducted by Credit Suisse of 24 primary care physicians and 27 endocrinologists found that “overall, physicians appear very excited by semaglutide's profile.” Credit Suisse's Vamil Divan noted in the same missive that the drug appears differentiated enough to expect “growth with rapid uptake,” adding that the uptake is likely to come from “both [Novo Nordisk's] Victoza as well as Trulicity.”
Still, there remain concerns about semaglutide's potential risk of retinopathy, an eye condition that can lead to blindness. Divan downplayed any potential black box warning accompanying the drug's approval, however, writing in an October 16 note that the data demonstrating a link between the drug and the eye condition is considered “inadequate.”
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However, other researchers noted that more data may be needed to understand semaglutide's risk of retinopathy. Dr. Leon Henderson-MacLennan, a medical advisor for inThought Research, said in an interview that “more mature data” is needed to better understand the retinopathy risk.