Topics:

Incivek patients died from skin reactions, Vertex says

FDA adds 'black box' warning to hep C drug's label
Tools
Vertex Pharmaceutical's Incivek

Vertex Pharmaceuticals ($VRTX) has some serious news about its hepatitis C drug Incivek: Some patients have died from serious skin reactions. The treatment, approved last year, was known to cause rash and skin reactions in some people, but this is the first time Vertex has reported deaths from those reactions.

As the Boston Business Journal reports, FDA has now slapped a "black box" warning on Incivek, amping up the cautionary language already included on the drug's official label. The safety issue could put a damper on Incivek as newer products near approval.

Vertex wouldn't say how many Incivek patients had died. The label update "follows reports of a small number of fatal skin reactions in patients who continued to receive Incivek combination therapy after a serious skin reaction was identified," the company said in a statement.

Incivek was Vertex's first drug on the market, and it still accounts for most of the company's sales. As the Boston Globe reports, Vertex's third-quarter revenues amounted to $336 million, $254 million of which derived from Incivek. The drug's sales were strong from the get-go, even in the face of competition from Merck's ($MRK) new hep C treatment Victrelis. But all-oral combination therapies being developed by other drugmakers, including Gilead Sciences ($GILD), threaten to eclipse both Incivek and Victrelis.

- see the Vertex statement
- read the Boston Globe story
- get more from the Boston Business Journal

Special Report: Hep C pill race report 2012: Gilead, others rush toward pharma gold

Related Articles:
Vertex records loss as Incivek sales lag
Vertex partners with J&J, GlaxoSmithKline on new hep C 
Vertex dumps one hep C dud, races ahead with second all-oral hope