Vertex’s VX-135 partial hold signals heightened FDA scrutiny toward HCV drugs

Vertex’s VX-135 partial hold signals heightened FDA scrutiny toward HCV drugs

By Christine Livoti in New York

Vertex Pharmaceuticals’ (NASDAQ:VRTX) hepatitis C virus (HCV) drug VX-135 and the recent partial clinical hold placed on it signal heightened FDA scrutiny toward HCV drugs, experts said. 

Still, most experts expressed optimism the partial hold will be removed and that the 200mg dose will advance. 

Other therapies developed to treat HCV that are similar to VX-135, a direct-acting antiviral (DAA) have been shown to trigger only transient elevations in liver enzymes, which are less of a concern.... 

Mild ALT increases seem to be quite common with many DAAs, a second European expert added. Either the elevation associated with VX-135 must be higher or the frequency greater than what has been observed with other DAAs to merit the partial clinical hold, he speculated....

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