Sponsored By

Vasogen Trial Stymied by FDA ReversalVasogen Trial Stymied by FDA Reversal

FDA has reversed itself over patient-recruitment and statistical-analysis issues for Vasogen Inc.'s Celacade System, a combination product that treats heart inflammation. Responsibility for lead review has been switched from CDRH to CBER (though the product will remain regulated as a medical device). CDRH had asked the company to use a Bayesian study design, but it now says the approach is not justified because of concerns about how patients in the product's two main studies were recruited.

March 3, 2008

1 Min Read
Vasogen Trial Stymied by FDA Reversal

The company says it will respond to the agency soon.Vasogen was named one of MD&DI's 50 Companies to Watch in 2006. What this means is that the watch will last longer than expected before it's known whether the firm will have success.UPDATE: On April 14, 2008, Vasogen said it would cease funding studies for Celacade and shift focus to a different field. It also said it would cut 85% of its work force.

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like