PHARMACY

Nonprofits urge for more means of addressing obesity epidemic

BY Alaric DeArment

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The Obesity Society and the Obesity Action Coalition said Monday that they were urging the FDA Endocrine and Metabolic Drugs Advisory Committee to consider the need for more measures against obesity as the committee reviewed an application for Orexigen Therapeutics’ anti-obesity drug Contrave (naltrexone and bupropion), with the review scheduled for Tuesday.

Obesity affects some 93 million Americans, but the FDA has turned down approval applications for two obesity drugs, including Vivus’ Qnexa (phentermine and topiramate) and Arena Pharmaceuticals’ Lorquess (lorcaserin), while requesting that Abbott’s weight-loss drug Meridia (sibutramine) be removed from the market due to safety concerns.

“We are deeply concerned about the effect that the FDA’s recent decisions will have for ongoing and future research into desperately needed new obesity treatments,” Obesity Society president Jennifer Lovejoy stated. “As the FDA’s advisers consider the application before them, we hope that the agency will assure a balanced process, taking into account the urgent medical need.”

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Watson, Natco ink deal for generic Revlimid

BY Alaric DeArment

MORRISTOWN, N.J. — U.S. generic drug maker Watson Pharmaceuticals and Indian drug maker Natco Pharma will work together to develop and commercialize a generic drug used for bone marrow disorders, the two companies said Tuesday.

The agreement concerns lenalidomide tablets in the 5-mg, 10-mg, 15-mg and 25-mg strengths. The drug is a generic version of Celgene’s Revlimid, used to treat the plasma cell cancer multiple myeloma and myelodysplastic syndrome. Myelodysplastic syndrome results from the bone marrow producing blood cells that are misshapen.

Under the agreement, the companies will share net profits. The companies said Natco may be the first company to apply for Food and Drug Administration approval, which would give the companies 180 days of market exclusivity once the agency approves the application.

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Bristol-Myers Squibb seeks additional approval for Orencia

BY Alaric DeArment

PRINCETON, N.J. — The Food and Drug Administration has accepted for review a supplemental approval application for an arthritis drug made by Bristol-Myers Squibb, the drug maker said Monday.

Bristol is seeking approval for Orencia (abatacept) injected into the skin as a treatment for adults with moderate to severe rheumatoid arthritis. The drug already is approved for intravenous injection.

The company filed the application in October after a phase-3 trial program of 1,847 patients showed that patients receiving weekly skin injections of the drug showed about the same degree of improvement as those receiving the drug by IV.

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