Please login to the form below

Not currently logged in
Email:
Password:

Janssen Invokana combination recommended for European approval

Drug adds metformin to the firm's new SGLT2 inhibitor

J&J Janssen Invokana canagliflozinEMA 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).

Article by
Dominic Tyer

24th February 2014

From: Sales, Regulatory

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
TRIDUCIVE

Triducive are a strategic healthcare consultancy who produce communications that have practical, dynamic application that encourage behaviour change because of the...

Latest intelligence

PME-MAY21-Cover
Avoiding A Series of Unfortunate Events: launch lessons from lockdown
Chris Ross takes a novel look at launch excellence through the lens of COVID-19 and explores how pharma’s launch leaders are rewriting the story...
6 reasons patients drop out of clinical trials and 6 ways to fix it
If you’ve successfully recruited patients for your clinical trial, but one by one, they begin to drop out, then this information could be for you....
Sharing patient stories for World Pulmonary Hypertension Day
For World Pulmonary Hypertension Day and we’re here to help raise awareness of pulmonary hypertension (PH) - a frequently under and misdiagnosed condition. Created in collaboration with the PH patient...