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Arena Pharma's weight loss drug lorcaserin moves closer to approval

EMA accepts obesity drug's marketing application and FDA will reconsider its US application in May

Arena Pharmaceuticals' obesity treatment lorcaserin has moved a step closer to approval in Europe and the US.

The European Medicines Agency (EMA) has accepted the drug's marketing authorisation application for review, and stateside Food and Drug Administration (FDA) advisors will meet in May to reconsider lorcaserin's US licence application.

Arena and its partner Eisai, which has exclusive rights to market and distribute lorcaserin in the US, ran into problems with their first attempt to win a US licence, when the FDA declined to approved the drug..

In its October 2010 Complete Response Letter, the agency cited a number of problems with lorcaserin, including insufficient evidence of efficacy and safety concerns stemming from the development of tumours in rats who were administered the drug.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet on May 10, 2012, to discuss lorcaserin's New Drug Application (NDA) resubmission.

"We are working diligently with Eisai to prepare for the FDA advisory committee meeting in May," said Arena's vice president of global regulatory affairs Audet. "We look forward to lorcaserin's PDUFA date in June as well as reporting on developments related to the MAA throughout the year."

Arena is seeking a licence for the drug in weight control, including weight loss and maintenance of weight loss, in patients who are obese or overweight and have at least one weight-related co-morbid condition.

The drug is a new chemical entity that is believed to act as an agonist of the selective serotonin 2C receptor, an area believed to be involved in the control of appetite and metabolism.

Just last week FDA advisors voted in favour of a rival obesity treatment, Vivus' Qnexa, raising the possibility it could be approved in April. If approved, it would be the first new obesity drug to reach the US market in 13 years.

Following the announcements of lorcaserin's resubmission in the US and regulatory filing in Europe, Arena said its vice president of lorcaserin development Christen Anderson will retire at the end of this month.

27th March 2012

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