Shasun Pharmaceuticals - IndiaNivesh

Incivek (used to treat Hep C from Vertex) has been recommended by USFDA to include a "Black Box Warning" label.....Negative for Shasun, revise target price downward to Rs 181 (from Earlier Rs 233) & maintain BUY.

Vertex announced, as instructed by USFDA, the company has incorporated USFDA's most serious warning "Black Box Warning" on the label of Incivek (Telaprevir) following reports that some patients die from severe skin reactions after taking it in combination with Peginterferon alfa & Ribavarin (Incivek combination treatment).

According to USFDA, boxed warning of Incivek label would state that Incivek combination treatment must be immediately stopped in patients experiencing a rash with systemic symptoms or a progressive severe rash.

Though rash & serious skin reactions were known side effects of Incivek and have been reported previously. However, this is the first time the company has reported that such reactions have resulted in fatalities. According to company, in phase 3 clinical trials less than 1% patients who received Incivek combination treatment experienced serious skin reaction.

Source : Equity Bulls

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