FDA approves potential blockbuster drug for Vertex
The US Food and Drug Administration today approved Incivek, a hepatitis C treatment that is expected to be a blockbuster drug for Vertex Pharmaceuticals Inc. of Cambridge.
Last month, a medical advisory committee unanimously recommended that telaprevir, the experimental drug Vertex developed to treat the liver-ravaging hepatitis C virus, be approved by the FDA. The agency typically follows the panel's advice. Incivek is the brand name that telaprevir will be marketed under.In a statement, Vertex chairman, president, and chief executive Matthew Emmens said: "Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure. The approval of Inciviek was only possible thanks to more than 4,000 people who volunteered for our clinical studies, the doctors, nurses, and coordinators who managed the studies, and our own pioneering scientists who have worked for more than 15 years to bring this new medicine to people with hepatitis C."
Vertex has been working on the treatment since 1993. Incivek will become the first drug commercialized solely by Vertex in its 22-year history, a recent Globe story noted.
The company is gearing up to compete with a rival tablet from Merck & Co. in a market that analysts project will initially top $2 billion a year, and could grow to $10 billion or more.
Blockbuster drugs are those that ring up more than $1 billion in annual revenue. The last one brought to market by a Massachusetts company was Tysabri, a multiple sclerosis treatment from Biogen Idec Inc. of Weston.
To read the FDA's press release, please click here.
To read Vertex's press release, please click here.
To read a recent Globe story about Vertex and its hepatitis C drug candidate, please click here.