The Cambridge, MA-based biotechVertex said Tuesday it has submitted an application to US FDA seeking speedy approval of its experimental hepatitis C drug telaprevir. The biotech company hoped the regulators could reduce their review process down to six months to clear the way for a commercial launch in the middle of 2011
“This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated,” said Matthew Emmens, the CEO of Vertex.
The company has achieved very impressive results from three late-stage clinical studies of this anti-virus agent. Phase III clinical data demonstrated that nearly all hepatitis C patients who respond early and robustly to the treatment with the telaprevir were effectively cleared of the virus after six months — reducing the conventional treatment time for the disease in half for a large group of patients. Patients with an extended rapid viral response had a 92 percent cure rate at 24 weeks and 88 percent at 48 weeks.
Other phase III trial indicated that the telaprevir cocktail treatment could lead to significantly higher cure rates compared to standard therapy in patients who failed to respond to prior treatment. Telaprevir is the first hepatitis C drug currently in development that has achieved such result.