New product launches
In addition to its robust drug portfolio, Novo Nordisk (NVO) boasts of a strong research pipeline across diabetes, hemophilia, obesity, and growth disorders segments. The company has submitted the investigational diabetes drug Xultophy and the faster-acting insulin Aspart as well as an investigational hemophilia B drug, N9-GP for review in the US.
The company had expected the FDA (US Food and Drug Administration) to do a complete review of Xultophy (IDegLira), a combination therapy made up of Glucagon-like peptide-1 (or GLP-1) therapy Victoza and basal insulin, Tresiba, for type 2 diabetes patients, by September 2016. However, on September 02, 2016, the company announced that the regulatory agency has extended the deadline and will complete the review by December 2016.
FDA had also extended the deadline for review of Sanofi’s (SNY) investigational diabetes drug, Lixilan, from August 2016 to November 2016. If approved, Lixilan is expected to be launched in the US prior to Xultophy, which may give Sanofi’s drug a first-mover advantage in the combination drug segment for diabetes.
Filed for review with the regulatory authorities both in the US and Europe for both type-1 and type-2 diabetes, faster-acting insulin Aspart is expected to give quicker and better results and lead to higher dosage flexibility than NovoRapid (insulin sApart). If approved in the US and Europe, Aspart should help Novo Nordisk pose strong competition to insulin drugs offered by GlaxoSmithKline (GSK) and Eli Lilly (LLY).
Novo Nordisk has submitted for review, N9-GP, for prophylaxis and for the treatment of bleeding in patients suffering from hemophilia B.
Notably, the International Dividend Achievers Portfolio (PID) has about 1.0% of its total portfolio holdings in NVO.
In the next part, we’ll analyze Novo Nordisk’s late-stage research pipeline in greater detail.