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Belviq cleared for US launch after abuse risk determined

Drug Enforcement Administration says Arena's weight loss drug has relatively low risk of abuse

Arena's Belviq cleared for US launch after abuse risk determined

Arena Pharmaceuticals' anxious wait to bring obesity drug Belviq to the US market is near an end, now that the Drug Enforcement Administration (DEA) has finally delivered a verdict on scheduling.

Belviq (lorcaserin) was approved by the FDA in June 2012, but Arena has had to wait months for the DEA to determine the level of abuse risk for the drug.

As it turns out the agency has classed it as schedule 4 – indicating a relatively low risk of abuse – but Arena and US marketing partner Eisai will still have to wait 30 days from publication of the scheduling in the Federal Register (which occurred May 8, 2013) before shipping can start.

After a long wait, it will be interesting to see if Belviq can make headway in the obesity market given that rival drug Qsymia (phentermine/topiramate) from Vivus – also approved last year and launched in September – has so far failed to make much of an impact.

Vivus reported sales of a little over $4m for Qsymia in the first quarter of 2013 – lower than expectations – and the company has now said it is seeking a partnership with a larger pharma company to help kickstart the product.

Some analysts have suggested that Qsymia is being held back by the availability of generic phentermine and topiramate which are sold under private label and at a tidy profit by weight-loss clinics.

Belviq has the advantage of being a new molecule, although it appears to be a little less effective than Qsymia in reducing weight, and because of a narrower effect on serotonin receptors also seems to have a reduced effect on heart rate compared with phentermine.

Eisai said it has set the price of Belviq at $199.50 for a month's supply of 10mg tablets in the US, which comes in at a premium to Qsymia (with a list price of around $120-$185 depending on the dose).

People in Europe hoping to get hold of Belviq will have to be patient, however, as Arena withdrew its application to market the drug in the EU after a request for more data from the European Medicines Agency's Committee for Medicinal Products for Human Use.

9th May 2013

From: Sales, Regulatory

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