EU Rejects Obesity Drug Qsiva for the Second Time
The European Medicines Agency (EMA) has again refused to grant approval for the new obesity treatment phentermine/extended-release (ER) topiramate (Qsiva, Vivus) in the European Union.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) first rejected the product in October but was asked by the company to reexamine the decision.
Defending its second rebuttal, the CHMP said it “has concerns about the medicine’s long-term effects on the heart and blood vessels, particularly due to the effects of phentermine, which is known to increase the heart rate but whose long-term effects are not clear.” Second, there are “concerns about the long-term psychiatric effects and cognitive effects related to the topiramate component of Qsiva,” it noted.
The EMA noted that there was a high probability that, if approved, “the medicine would not be used strictly for the intended patients. The applicant did propose measures to reduce this risk, but the measures were considered difficult to implement in practice,” so it concluded that “the benefits of Qsiva did not outweigh its risks.”
Read the Full Article at http://www.medscape.com/viewarticle/779897?nlid=28903_1301&src=wnl_edit_dail
Source: by Lisa Nainggolan on February 26, 2013 for Medscape Medical News at http://www.medscape.com/viewarticle/779897?nlid=28903_1301&src=wnl_edit_dail
