EMA panel backing for Novo Nordisk's Tresiba and Ryzodeg: Japanese review

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday announced its positive opinions, recommending marketing authorizations for Danish insulin giant Novo Nordisk’s (NOV: N) Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes mellitus in adults.

Novo Nordisk has touted the products as having blockbuster potential, ie, annual sales of over $1 billion, and set to compete with Sanofi’s Lantus (insulin glargine), which holds some 80% of the global market for long-acting insulins and sales of 3.92 billion euros (around $5 billion) last year. Both Novo Nordisk products are still under review by the US Food and Drug Administration, which has scheduled an advisory panel meeting to review the drugs on November 8 (The Pharma Letter July 19). Analysts at EvaluatePharma have forecast that degludec sales will reach $1.4 billion by 2016 (TPL January 20).

Tresiba is a new generation of once-daily basal insulin. In “treat-to-target' studies supporting the new drug application, where the product was compared to insulin glargine, Tresiba demonstrated a significantly lower risk of overall and nocturnal hypoglycemia, while successfully achieving equivalent reductions in HbA1c, the company noted. Furthermore, with a duration of action beyond 42 hours, Tresiba is the first basal insulin to offer patients the possibility of adjusting the time of injection, when needed.

Ryzodeg contains insulin degludec in a soluble formulation with insulin aspart. Ryzodeg can be administered once or twice daily with the main meal(s). In “treat-to-target' studies supporting the new drug application, where Ryzodeg was compared to Novo Nordisk’s NovoMix (biphasic insulin aspart). Ryzodeg demonstrated a significantly lower risk of overall and nocturnal hypoglycemia while successfully achieving equivalent reductions in HbA1c.  In Europe, Tresiba and Ryzodeg will be available in FlexTouch, the company’s latest prefilled insulin pen, which has an easy auto-injector mechanism.