Vertex's HCV Drug Might Gain Advantage Over Merck's From FDA Draft Guidance
FDA’s draft guidance on chronic hepatitis C drug development inspired one analyst to predict an advantage for Vertex Pharmaceuticals’ telaprevir over Merck & Co.’s boceprevir.
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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).
The FDA commissioner also does not want the agency setting goals for rare disease treatment development.
Expedited approval pathway had been a secondary option when traditional approval was not possible, but the CBER director wants surrogate endpoints increasingly considered from the beginning, especially with pediatric rare disease gene therapies.