Novo Nordisk submits GLP-1 agonist semaglutide for regulatory approval in Japan – March 3, 2017

Novo Nordisk announced yesterday that it has submitted a New Drug Application (NDA) for the Japanese regulatory approval of once-weekly GLP-1 agonist semaglutide. Assuming a standard 12-month Japanese review process, a regulatory decision for Japan is expected in 1Q18. This news comes on the heels of Novo Nordisk’s submission of semaglutide to the FDA and EMA in December 2016 – regulatory decisions from these bodies are expected in 4Q17. This is tremendously exciting news given the incredible potency of the semaglutide compound, as demonstrated in the phase 3 SUSTAIN program. As we understand it, semaglutide packs a bigger punch than Novo Nordisk’s current market-leading GLP-1 agonist Victoza (liraglutide) in terms of A1c efficacy, weight reduction, and potentially renal and cardioprotection, all in a more convenient once-weekly dose formulation. We certainly see best-in-class potential for semaglutide from an efficacy perspective, though of course potentially disruptive GLP-1 agonists are on the horizon as well, including Novo Nordisk’s own oral formulation of semaglutide and Intarcia’s implantable ITCA 650 (exenatide mini-pump). This series of filings for semaglutide comes during a period of tremendous growth for the GLP-1 agonist class: total GLP-1 agonist revenue neared $5 billion in 4Q16, up 26% year-over-year according to our latest pooled market analysis. These are certainly exciting times, and we will be following semaglutide’s progress in Japan, Europe, and the US closely. We are particularly curious to learn how Novo Nordisk will position semaglutide within its extensive portfolio of diabetes products. The company noted in its 4Q16 update that marketing resources are currently prioritized toward Victoza and Tresiba – so much so that soon-to-be-launched Xultophy (insulin degludec/liraglutide) may not be broadly promoted in the US for several months or years. It’s unclear what this means for semaglutide, but we hope that patients and providers are made very aware of this potentially best-in-class drug. That said, based on management’s extremely positive commentary on semaglutide, we expect much of the resources devoted to Victoza currently will shift toward semaglutide upon its approval, especially given Victoza’s impending patent expiry.


-- by Abigail Dove, Helen Gao, and Kelly Close