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Liraglutide seems effective in obesity, says FDA reviewer

Novo Nordisk drug is already successful diabetes treatment
Novo Nordisk headquarters

Novo Nordisk could open a lucrative new market for its GLP-1 agonist liraglutide if an FDA advisory committee endorses its use in obesity at a meeting tomorrow.

Liraglutide is already a major earner for the Danish pharma company as a diabetes therapy - for which it is sold as Victoza and brought in 6bn krone (around $1bn) in the first half of the year - but some analysts have suggested approval in obesity could add another $1bn a year to sales.

A briefing document published by the FDA ahead of the advisory committee suggests the drug has a fair chance of being recommended for approval, with the agency's reviewer indicating it appears to be effective as an adjunct to diet and exercise for weight control.

Specifically, the document indicates that a 3mg daily dose of liraglutide helped 60% of obese patients lose 5% of their body weight, while a third achieved a 10% reduction, which indicated the drug was twice as effective as placebo.

On the downside, the safety summary in the report does refer to a higher number of breast malignancies in women who took liraglutide compared to placebo, although it stops short of suggesting any causal link with the drug.

Approval of liraglutide in obesity could be a transformative event for weight loss therapy, which has seen a string of pipeline disappointments. Even those products that have navigated their way through the regulatory pathways to market - such as Arena Pharmaceuticals/Eisai's Belviq (lorcaserin) and Vivus' Qsymia (phentermine/topiramate) - have so far not proved to be commercial winners.

The wealth of clinical experience with liraglutide in diabetes, coupled with the fact that it avoids troublesome central nervous system side effects that have plagued centrally-acting obesity drugs, could stand in its favour.

Novo Nordisk Victoza liraglutide diabetes  

Liraglutide is already marketed as the diabetes treatment Victoza

Meanwhile, Novo also has a clinical trial ongoing to establish whether treating obese patients with the GLP-1 agonist could delay the onset of diabetes, which would immediately differentiate it from its rivals, as well as a study seeing if it can reduce life-threatening sleep apnoea.

Novo's chief executive Lars Rebien Sørensen identified liraglutide in obesity - which would be sold under the Saxenda brand name - as one of the key factors that will drive the company "back into double-digit growth" after a rocky period for the company.

The FDA turned down its marketing application for long-acting insulin therapy Tresiba (insulin degludec) last year, asking for additional cardiovascular safety data, while the company decided to drop its R&D programme in inflammation after the failure of anti-interleukin-20 (IL-20) drug NN826 in rheumatoid arthritis.

Article by
Phil Taylor

10th September 2014

From: Sales, Regulatory



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