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.