Please login to the form below

Not currently logged in
Email:
Password:

CHMP thumbs up for Novo's obesity drug Saxenda

Diabetes drug liraglutide on course for new indication in EU

Novo Nordisk headquarters 

Novo Nordisk is gearing up for approval of its obesity drug Saxenda in Europe, after a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

Saxenda (liraglutide) is a once-daily glucagon-like peptide-1 (GLP-1) analogue that was first approved for obesity in the US a month ago, and is based on the same active ingredient as Novo Nordisk's $2bn-a-year diabetes therapy Victoza.

The new indication could boost sales of the company's liraglutide franchise by up to $1bn a year, according to analysts.

Saxenda has a chance of revitalising the obesity treatment market, which despite an enormous patient population has seen lacklustre sales in recent years even after the entry of a trio of new products - Eisai and Arena's Belviq (lorcaserin), Vivus' Qsymia (phentermine/topiramate) and Orexigen's Contrave (naltrexone and bupropion) in the last couple of years in the US and other world markets.

The picture in Europe is different, however, given that the European Medicines Agency (EMA) declined to approve both Belviq and Qsymia on safety concerns, although the CHMP did back Orexigen's drug under the Mysimba brand name last December.  

The latest development means European doctors could have three drugs at their disposal to manage obesity patients in the coming months, with Saxenda and Mysimba slotting into the market alongside Roche's lipase inhibitor Xenical (orlistat), which was first launched in 1999 and makes around $400m a year in sales.

The wealth of clinical experience with liraglutide as a diabetes drug - albeit at a lower dose - should give doctors confidence to prescribe it for weight control, although as an injectable drug it could face some resistance from patients, given that its rivals are taken orally.

Datamonitor concluded recently that Saxenda was the product "most likely to grow the obesity market."

Novo Nordisk is also developing a follow-up GLP-1 analogue called semaglutide that has just entered phase II testing and seems to achieve greater weight loss than liraglutide in animal and preliminary human studies.

The drug is thought to accumulate in an area of the brain that governs appetite more readily than liraglutide, which could explain its more sustained activity, according to Mads Krogsgaard Thomsen, Novo's chief scientific officer.

Prevenar 13 also backed

Meanwhile, the CHMP has also issued a positive opinion for an application by Pfizer to extend the indications for its pneumococcal vaccine Prevenar 13 to include the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults 18 years and older.

The vaccine is currently approved in Europe for the prevention of invasive pneumococcal disease in the same population.

Article by
Phil Taylor

23rd January 2015

From: Sales

Share

Tags

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
KVA Digital

KVA is an award winning full-service digital communications & brand experience agency. Our healthcare expertise blends creative ‘outside-the-box’ thinking with...

Latest intelligence

Has the pandemic opened up a future of accelerated diagnosis and better care for rare disease patients?
The challenge with rare disease is in the name – it's rare, so awareness is limited and diagnosis hindered. Could a more virtual existence change this? A Medical Affairs viewpoint...
The other side of … blood cancer
To stay motivated for the fight, some patients need to feel like active players in the treatment journey, not passengers to every decision....
COVID clinical trial
COVID-19 – a catalyst for technology adoption in clinical trials
As the COVID-19 crisis disrupts clinical trials around the globe, it is also proving to be a catalyst that may transform its approach to trials for good...

Infographics