Vertex' hep C drug Incivek to carry boxed warning in USA; UK to fund Kalydeco

US drugmaker Vertex Pharmaceuticals (Nasdaq: VRTX) says that the label on its new hepatitis C drug Incivek (telaprevir) in the USA has been updated to include a Boxed Warning stating that fatal and non-fatal serious skin reactions have been reported in patients taking Incivek combination treatment.

Fatal cases of serious skin reactions have been reported in patients with progressive rash and systemic symptoms who continued to receive Incivek combination treatment after a serious skin reaction was identified.

Incivek, which was approved by the US Food and Drug Administration last year (The Pharma Letter May 24, 2011), had 2011 US annual sales of $951 million and was estimated to reach 2012 sales of $1.19 billion, according to BioPharm Insight data. However, on its third-quarter earnings call, the company announced a continued decline in Incivek sales. Total Incivek revenues were around $254 million, down from $327.7 million in the second quarter. Previously, Vertex lowered full-year Incivek sales estimates to $1.1 billion-$1.25 billion from a prior forecast of $1.5 billion-$1.7 billion.