FDA votes against an 'okay' for Sanofi's anti-clotting medication

The rejection of the approval of the anti-clotting drug Semuloparin, from the Sanofi pharmaceutical by the FDA officials was done due to its associated risk of clotting in cancer patients and also the failure from the drug manufacturer's side.

Fontana, CA (prHWY.com) July 23, 2012 - 23 July 2012, USA(Acedrugstore.com): Semuloparin, an anti-clotting medicament produced by one of the pioneer global pharmaceutical company, Sanofi has encountered a big blow from FDA, when the expert panel of the drug regulatory agency voted against the approval of the drug for use in cancer patients.
This was the first new medication from Sanofi, which has not marketed any new drug in the market for almost a period of two years.
The expert panel has voted against the drug with certainty and claimed that the investigative studies submitted by the executives and R&D officials of Sanofi failed to provide a clear picture of the accurate and beneficial use of the medication in its targeted patients. And, the inability of the proper target patients led to perturbing of their bleeding risk.
The vote of 14 to 1 itself against the drug curbed down its chances of acquiring any further approval of the medication by the FDA. Also, the drug regulatory agency has clearly stated that the failure of the R&D experts of Sanofi to defend their work and give an evocative support to their work led to thumbs down from the FDA.

Also, the fact that some of the patients experiencing clotting issues despite taking the aid of the drug and the death of certain others added to its failure from approval.
Dr. Mikkael Sekeres from a reputed Cancer Institute said that people suffering from cancer and undergoing chemotherapy approach have to go through a lot of stress and pain to deal with their health condition and hence, the approval of any medication for preventing their complications should be done very carefully, such that their health condition is not further aggravated.
Sanofi in a press release later claimed that currently there are no treatment approaches available for people undergoing chemotherapy to prevent their clotting risk.
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