EMA advisors have recommended a pill that combines Janssen’s Invokana with the older diabetes drug metformin be approved in Europe.
The CHMP’s positive opinion on Vokanamet puts the type 2 diabetes treatment on the path to full approval in the region within the next three months.
Its key component, the first-in-class Invokana (canagliflozin), was approved in the EU last November and received a US licence in March 2013, but the metformin combination has been held up stateside after the FDA requested more data on dosing.
If approved in Europe Janssen‘s fixed dose combination could provide a more convenient treatment option for the treatment of adults with type 2 diabetes by reducing their pill burden.
Invokana works by blocking the human sodium-glucose co- transporter-2 (SGLT2) protein in the kidney and increasing the excretion of glucose in urine, which means it works completely independently of a diabetic patient’s insulin function. Meanwhile Metformin works by suppressing glucose production by the liver.
Professor Guntram Schernthaner from the Department of Medicine I in Austria’s Rudolfstiftung Hospital, said that, if approved, Vokanament would offer patients “the benefits of blood glucose and body weight reduction without increasing the risk for hypoglycaemia”.
The company will have to implement a pharmacovigilance plan for Vokanamet as part of any marketing authorization and the CHMP noted that the most common side effects of canagliflozin include hypoglycaemia (when used in combination with insulin or a sulphonylurea).