As reported in Xconomy, Vertex has filed an NDA for its new treatment, telaprevir, for hepatitis C infection. The company is asking the FDA for Priority Review which generally occurs in 6 months instead of the normal 10 months.
Vertex Seeks FDA Green Light for Hepatitis C Drug; Chomps at the Bit For Fast Review.
The priority review request is based on the results of three Phase III trials with over 2000 patients. The three trials established the following in Vertex's point of view:
- Telaprevir in combination with standard meds coudl cure 3/4 of patients getting their initial round of therapy
- Telaprevir can shorten the standard treatment by 50%
- Telaprevir could cure 2/3 of patients who failed to respond in a prior round of therapy
Taken together, Vertex expects to introduce a new treatment regimen that will roughly double the cure rate of the existing regimen while also delivering fewer side-effects. There are an estimated 6 million patients in the US and Europe, with another 170 million worldwide. Vertex could experience annual sales of more than $2 B per year in the US alone due to pent up demand for a more effective hepatitis C treatment.
Posted by Bruce Lehr November 23rd 2010.
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