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Novo Anticipates Q4 Soft Launch For Closely Watched Oral GLP-1 Agent Rybelsus In The US

 
• By Mandy Jackson

US CMO Todd Hobbs told Scrip the full launch will be in early 2020 as sales, manufacturing and reimbursement preparations for oral semaglutide continue based on the now-approved FDA label in type 2 diabetes.

Form close up, fountain pen and approved stamped on a document. Soft focus. - Image
The US FDA approved Rybelsus, the first oral GLP-1 agonist. • Source: Shutterstock

Fourteen years after the first approval of an injectable glucagon-like peptide-1 (GLP-1) agonist for the treatment of type 2 diabetes, Novo Nordisk AS won US Food and Drug Administration for the first oral GLP-1 agent – Rybelsus (semaglutide) – on 20 September.

Novo Nordisk US chief medical officer Todd Hobbs told Scrip in an interview that the company anticipates a soft initial launch in the fourth quarter of this year while sales teams are trained to market Rybelsus according to its label, as manufacturing is ramped up to meet commercial demand and while reimbursement negotiations with US payers to secure patient access continues

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