Arena’s lorcaserin to receive FDA review
SAN DIEGO Arena Pharmaceuticals obesity drug lorcaserin is expected to clear a key safety review this month, according to Reuters.
The drug blocks appetite signals in the brain. There have been concerns though that drug may have a fatal side effect, heart valve damage. Redux, lorcaserin’s parent drug manufactured by Wyeth was pulled off the market because it was linked to heart valve damage. But, the difference between the drugs is that Redux was hitting too many biological receptors on top of the one that reduces appetite.
Arena has been conducting a safety review of the drug in hopes of getting it approved by the Food and Drug Administration. The results of that year long review will be released some time this month and so far, at six months, there was no evidence of heart valve damages.
Arena has enrolled about 3,200 patients in the Phase 3 trial and will study them for two years. The safety board will review echocardiograms of patients again at 18 and 24 months, but the trial’s main goal is efficacy at 12 months, the period just ended, Arena chief executive Jack Lief said.
He said the study will conclude early next year and the company expects to file for regulatory approval of lorcaserin toward the end of 2009.
Possible new FDA diabetes drug guidelines could delay approvals
SAN DIEGO A draft of new guidelines proposed by the Food and Drug Administration for developing drugs to treat diabetes may lead to a delay of the approval for a new long-acting diabetes drug from Amylin Pharmaceuticals, according to the Associated Press.
The FDA suggested increased testing for macrovascular complications, or diseases affecting large veins, particularly for drugs that are linked to problems with those veins.
That could delay approval of Amylin’s diabetes drug candidate exenatide LAR, a weekly version of its Byetta treatment and a Type 2 injectable diabetes drug, which it co-manufactures with Eli Lilly, Lazard Capital Markets analyst Matthew Osborne wrote in a note to clients Monday. He said the guidelines could make clinical trials of diabetes drugs more expensive and difficult.
FDA approves Ranbaxy’s generic version of Risperdal
NEW DELHI, India Ranbaxy Laboratories has received approval from the Food and Drug Administration for a generic version of Janssen Pharmaceuticals’ schizophrenia drug, Risperdal, according to published reports.
Risperdal is also used to treat such behavior problems as aggression and self-injury, as well as sudden mood changes in teenagers and autism in children. The company has received approval to launch the generic risperidone in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg strengths.
Risperdal had sales of $924 million in 2007.