COPENHAGEN: Danish drugmaker Novo Nordisk came closer to winning European approval for diabetes drug Ozempic, it’s biggest growth prospect when a European Medicines Agency (EMA) experts’ panel issued a positive recommendation on Friday.
The once-weekly injection, known generically as semaglutide, is an important driver for offsetting the margin squeeze Novo Nordisk is experiencing in its traditional insulin franchise due to price pressure.
The recommendation from EMA’s Committee for Medicinal Products for Human Use would need to be formally endorsed by the European Commission before the drug can be marketed in the European Union. Novo Nordisk said it expects to receive final marketing authorization in the first quarter of 2018.
Ozempic was approved by the U.S. Food and Drug Administration this month.
Novo Nordisk hopes Ozempic will take market share from Eli Lilly’s Trulicity, which has been cutting into sales of Novo’s once-daily Victoza.
Ozempic, Trulicity, and Victoza are all so-called glucagon-like peptide-1 (GLP-1) analogs, which imitate an intestinal hormone that stimulates the production of insulin.
Analysts on average expect annual sales of Ozempic to reach $3.17 billion by 2023, with sales of Trulicity, which was approved in the United States in late 2014, reaching $3.71 billion over the same period, according to Thomson Reuters data.
Ozempic is set to become Novo’s biggest drug, according to analysts, who predict it will account for around 20 percent of sales in 2025.
(Reporting by Stine Jacobsen; Editing by Adrian Croft and Susan Fenton)