Vertex Pharmaceuticals Inc. said it has finished submitting its hepatitis C drug candidate to the U.S. Food and Drug Administration for approval. The submission is widely seen as a watershed moment for the company because the drug, if approved, is expected to be a blockbuster. If so, Vertex, after more than 20 years, would join the elite ranks of profitable biotechnology companies.
The Cambridge-based company’s FDA application is based on extensive data from three Phase 3 clinical trials testing both patients that were new to treatment and those who had previously received available treatments but had not attained a viral cure. To date, more than 2,500 people with genotype 1 hepatitis C have received the potential drug.