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FDA recommends Arena-Eisai’s weight loss drug Lorqess

Could beat Vivus’ Qnexa to market as first weight loss medicine approved in US since 1999

The US Food and Drug Administration (FDA) has recommended Arena's weight loss drug Lorqess be approved, bringing it one step closer to a US market which hasn't seen a new treatment launched since 1999.

The drug, which is to be marketed and distributed by Eisai if approved, had previously been turned down by the FDA in October 2010, when the agency citing several issues with the drug related to both its efficacy and safety including the development of tumours in rats that had been given the drug.

Following the submission of new data from Arena, however, an FDA advisory committee voted 18 to 4 in favour that the drug had demonstrated that its ability to achieve and maintain weight loss in obese people outweighed its potential risks.

This could give Lorqess (lorcaserin) the edge in beating Vivus' Qnexa (phentermine/topiramate) to market after the FDA delayed its decision on Vivus' therapy until July 17, 2012, following a request for more data.

Qnexa had previously been recommended by an FDA panel in February, 2012 after Vivus also had to provide further safety data following an initial rejection for its application in 2010.

According to Arena, the target date for the FDA to complete its review of Lorqess is June 27, 2012, which would make it the first new weight loss drug available in the US in 13 years.

"The advisory committee's positive vote supports our belief in lorcaserin as a potential new treatment option for the medical management of overweight and obesity," said Jack Lief, Arena's president and CEO.

"We will continue to work with the FDA as the agency completes its review of the lorcaserin new drug application."

In addition to the FDA recommendation, Arena also announced it would expand its marketing and supply agreement with Eisai regarding Lorqess.

The new agreement will see Eisai gain exclusive rights to market and distribute the product in most of North and South America, including Canada, Mexico and Brazil, in addition to its current US rights.

Arena is eligible to receive increased payments based upon Eisai's net sales of the drug in the US and other territories, as well as regulatory and development milestone payments.

In Europe, Lorqess is currently under review by the European Medicines Agency (EMA).

14th May 2012

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