FDA Rejects Arena's Diet Pill lorcaserin
FDA Rejects Arena's Diet Pill lorcaserin
In recent pharma news is the rejection of arena's promising weight reduction pill by FDA
Arena pharmaceutical, based out of California,is research based bio-pharmaceutical company, generally working on development of drugs that target the activity of GPCRs (G-protein coupled receptors) generally in field of CVS,CNS, Inflammatory, metabolic area
1 year ago company detected promising molecule lorcaserin hydrochloride (lorcaserin),in treatment of weight management, successfully passed out phase - III clinical trials.
Lorcaserin was intended to duplicate the weight-reducing effect of one member of the fen-phen diet pill combination but without the side effects has succeeded in a small clinical trial, according to the drug's developer Arena Pharmaceuticals.
Company said that in clinical trial,obese patient who where given the highest dose of the Lorcaserin lost an average of 2.9 pounds after 28 days, compared with 0.7 pounds for those getting a placebo.
In December 2009, it submitted a new drug application (NDA),Food and Drug Administration (FDA) of USA, for regulatory approval.
on Friday, 22 Oct 2010 Arena announced that Food and Drug Administration has declined to approve Lorcaserin.
In September an advisory committee to the F.D.A. had voted 9 to 5 for rejection for approval,so rejection announcement is not quite surprissing.
The biggest issue behind declination of approval is meant to be production of tumors by Lorcaserin in higher dose in rat.
FDA asked for separate copy of data on animals & data assurance that result produced during higher dose in animal is not relevant with human.
The company's spokesman however told that the company has still hope that they will come back with more assured & PROMISING data,but what time was not specified.
Arena pharmaceutical, based out of California,is research based bio-pharmaceutical company, generally working on development of drugs that target the activity of GPCRs (G-protein coupled receptors) generally in field of CVS,CNS, Inflammatory, metabolic area
1 year ago company detected promising molecule lorcaserin hydrochloride (lorcaserin),in treatment of weight management, successfully passed out phase - III clinical trials.
Lorcaserin was intended to duplicate the weight-reducing effect of one member of the fen-phen diet pill combination but without the side effects has succeeded in a small clinical trial, according to the drug's developer Arena Pharmaceuticals.
Company said that in clinical trial,obese patient who where given the highest dose of the Lorcaserin lost an average of 2.9 pounds after 28 days, compared with 0.7 pounds for those getting a placebo.
In December 2009, it submitted a new drug application (NDA),Food and Drug Administration (FDA) of USA, for regulatory approval.
on Friday, 22 Oct 2010 Arena announced that Food and Drug Administration has declined to approve Lorcaserin.
In September an advisory committee to the F.D.A. had voted 9 to 5 for rejection for approval,so rejection announcement is not quite surprissing.
The biggest issue behind declination of approval is meant to be production of tumors by Lorcaserin in higher dose in rat.
FDA asked for separate copy of data on animals & data assurance that result produced during higher dose in animal is not relevant with human.
The company's spokesman however told that the company has still hope that they will come back with more assured & PROMISING data,but what time was not specified.
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