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FDA panel backs Novo Nordisk's liraglutide for obesity

Committee says diabetes drug could be used to reduce weight

Novo Nordisk US HQ 

Novo Nordisk's liraglutide should be approved to help reduce weight in obese people with at least one accompanying health issue such as high blood pressure, according to a US FDA advisory committee.

The panel voted by 14 to 1 in favour of the GLP-1 agonist - already sold to treat diabetes as Victoza - setting it on course for US approval in a new indication that could boost its sales to $1bn a year.

Expert advisors were satisfied with the safety profile of liraglutide in obese patients, despite some safety concerns raised in the data dossier.

These included an imbalance in the number of breast cancer cases seen in patients taking the drug versus placebo - which led to the one dissenting vote - and suggestions that some patients taking it had raised resting heart rates.

If the FDA follows its panel's advice and approves liraglutide for obesity it will be sold as Saxenda, according to Novo Nordisk, and will compete in the US marketplace against Eisai and Arena's Belviq (lorcaserin) and Vivus' Qsymia (phentermine/topiramate), which were approved last year to end a 13-year drought for obesity therapies in the US.

Saxenda will also go up against Orexigen's Contrave (naltrexone and bupropion), which was finally approved by the FDA yesterday after a three-year delay caused by FDA requests for more cardiovascular safety data.

Sales of both Belviq and Qsymia have been lacklustre in the US - despite the lack of drug therapies for obesity in the wake of the notorious 'fen-phen' incident which linked widely-used weight loss drugs to heart valve disorders - bringing in just $6m and $24m respectively last year.

Orexigen said yesterday that Contrave will have the benefit of a large Takeda salesforce promoting the drug and no need for scheduling for abuse risk by the Drug Enforcement Administration (DEA), which held up the launch of Belviq, and Novo Nordisk will claim similar advantages if the FDA follows its panel's advice and approves Saxenda.  The agency is due to deliver a verdict on liraglutide in obesity by October 20.

While the US has seen a crop of new pharmacological obesity therapies reach the market, Europe has been lagging behind, with the European Medicines Agency (EMA) declining to approve Belviq and Qsymia on safety concerns. At the moment, the only drug treatment available in the EU is Roche's Xenical (orlistat) or GlaxoSmithKline's lower dose, over-the-counter version Alli, with more profoundly obese patients offered surgery.

Both liraglutide and Contrave are, however, under regulatory review in Europe, so what was described as "pent-up demand" by delegates at the European Association for the Study of Obesity (EASO) in June may eventually be satisfied.

Article by
Phil Taylor

12th September 2014

From: Sales

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