FDA Approves New Hepatitis C, Cancer Drugs

July 30, 2015

The FDA approved the first-ever drugs that treat hepatitis C patients without interferon, under the agency’s priority review program.

The agency approved AbbVie’s Technivie (ombitasvir, paritarevir and ritonavir) for the treatment of hepatitis C virus genotype 4 infections in patients without scarring and poor liver function, and Bristol-Myer Squibb’s Daklinza (daclatasvir) to treat genotype 3 infections. Neither drug requires co-administration with interferon, a drug approved to treat HCV that causes side effects in nearly every patient.

Technivie’s approval came on the same day AbbVie reported second-quarter revenue of $5.5 billion, up 19.4 percent over the same quarter a year ago.

Last Friday’s bevy of approvals also included Novartis’ Odomzo (sonidegib) for locally advanced basal cell carcinoma that recurred following surgery or radiation therapy. About 58 percent of study participants who took the once-daily pill saw their tumors shrink or disappear for between two and nearly 19 months.

Another drug, Amgen’s Kyprolis (carfilzomib) received an expanded indication for injection in combination with Revlimid (lenalidomide) and dexamethasone to treat patients with melanoma who have received prior therapy. — John Bechtel