Third Telaprevir Pivotal Study Raises Bar For Competitors Another Notch
Collective top-line data from the Phase III program testing Vertex Pharmaceuticals' protease inhibitor telaprevir in treatment-naïve and treatment-experienced hepatitis C patients set a high bar for competitors, particularly for Merck & Co.'s boceprevir, with which telaprevir is dueling to be the first approved specifically targeted antiviral therapy for hepatitis C (STAT-C).
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Agency asks about data on prior null responders and about anemia effects. Merck has proposed a safety monitoring program while avoiding REMS terminology.
Dual FDA Advisory Committee Reviews Shaping Up To Be A Showdown For Dueling Merck And Vertex Hepatitis C Drugs
Approval is widely assumed for both boceprevir and telaprevir, but there is still much to be discussed about the devilish details. Additional data coming out at European liver meeting should also be informative.
With two direct acting antivirals now pending at FDA, the hepatitis C community is excited about adding efficacious new drugs to standard of care. But the regimens aren't as simple as that sounds; once the therapies are approved, the sponsors will have a considerable education effort on their hands, as physicians and patients work their way through the new HCV treatment calculus.