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12:00 AM
 | 
Apr 25, 2005
 |  BioCentury  |  Product Development

One down, one to go

After being asked by FDA for more clinical data on the risk-benefit profile for Ranexa ranolazine, CV Therapeutics Inc. obtained special protocol assessments for a pair of trials that the agency agreed would validate the therapeutic value of the anti-anginal candidate. While last week's Phase III results may have paved the way to market for a restricted population, long-term safety data from the second trial expected in 2006 hold the key to Ranexa's approval as a first-line therapy for chronic angina.

In 2003, FDA decided not to approve Ranexa despite that fact that the selective late sodium current blocker had met the primary endpoint in a pair of Phase III trials for chronic angina, due to the agency's uncertainty about the drug's risk-benefit profile. The...

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