Memorandum

Novo Nordisk’s Ozempic (semaglutide) approved in Canada – January 10, 2018

Health Canada yesterday approved Novo Nordisk’s GLP-1 agonist Ozempic (semaglutide once-weekly) for the treatment of type 2 diabetes. This news comes on the heels of Ozempic’s FDA approval and a CHMP endorsement for EMA approval.

While no details were shared on launch timing or pricing in Canada, Novo Nordisk’s cost strategy in the US is to price Ozempic on par with current leading once-weekly GLP-1s (presumably, Lilly’s Trulicity). We hope to see similar list price in Canada to maximize access and reimbursement prospects. Despite the nation’s universal public insurance system, Canada does not provide universal prescription drug coverage for its citizens, so reimbursement questions remain.

We’re very excited that patients in another geography will soon be able to take Ozempic. Novo Nordisk’s second-gen GLP-1 molecule has demonstrated impressive potency, and the reduced injection burden compared to once-daily Victoza (liraglutide) confers additional advantages to adherence and quality of life. Ozempic has shown superiority head-to-head vs. other available diabetes drugs, including AZ’s once-weekly GLP-1 agonist Bydureon and Lilly’s once-weekly Trulicity. All signs point to this being an extremely valuable addition to the diabetes treatment toolkit.

It’s unclear how retinopathy risk will be addressed on the Canadian label. As background, semaglutide was associated with a heightened risk for retinopathy in the two-year SUSTAIN 6 CVOT, but experts believe this could be due to “early worsening phenomenon,” wherein rapid A1c decline leads to a transient increase in adverse eye events, particularly in patients at higher baseline risk. As panelists emphasized at the FDA Advisory Committee meeting on semaglutide, tighter A1c control is still a better approach to avoid microvascular complications – including retinopathy – in the long term. The US label for Ozempic includes a warning for short-term increased retinopathy risk (the language is similar to that seen on insulin labels, since insulin has also been linked to early worsening of retinopathy for new patient starts). As part of requirements for European approval, Novo Nordisk has agreed to conduct long-term post-market studies probing for retinopathy outcomes with Ozempic treatment.

Final marketing authorization for Ozempic in Europe is anticipated in 1Q18, as is product launch in US pharmacies.

 

-- by Payal Marathe and Kelly Close