The US Food and Drug Administration’s (FDA’s) Endocrinologic and Metabolic Drugs Advisory Committee has backed Arena Pharmaceuticals and Eisai’s obesity drug, lorcaserin.
The panel voted 18 to four, with one abstention, ruling that available data demonstrated that lorcaserin’s benefits outweigh the potential risks through long-term use.
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The panel’s backing comes ahead of a final decision on the drug, which is expected to be heard before 27 June 2012. Lorcaserin was originally rejected by the FDA in 2010, with the agency citing concern over tumours found in animal studies and modest weight loss.
Despite the positive vote, concerns are still being raised surrounding the drug’s safety profile, with some panellists apprehensive over an excess risk of valvular heart disease.
Cedars-Sinai Medical Center vascular physiology and thrombosis research laboratory director Sanjay Kaul said: "The weight loss did not translate into a tangible benefit in clinically relevant cardiometabolic biomarkers, quality of life, or risk prediction models."
Despite the concerns, Arena president and CEO Jack Lief remained upbeat about the drug’s chances of approval and pledged to continue to work with the FDA as it completes its review of lorcaserin.
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By GlobalData"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," added Lief.
