Janssen receives positive CHMP recommendation for hep C drug

Janssen has announced it has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP), which has suggested the company's simeprevir chronic hepatitis C treatment should be granted marketing authorisation in the European Union.

The once daily 150 mg drug has proven its efficacy across a range of different hepatitis C virus types in phase III studies involving more than 1,000 patients.

Brian Woodfall, head of development and global medical affairs at Janssen's infectious diseases and vaccines division, said: "The CHMP positive opinion for simeprevir brings us another step closer to delivering an innovative therapy for patients suffering from this devastating disease."

Across three clinical trials, the treatment met all primary endpoints and demonstrated simeprevir – when administered in combination with pegylated interferon and ribavirin – achieves superior results than those two drugs alone for treatment naive and prior-relapser patients.

Following the studies, it was found less than five percent of those involved experienced adverse side-effects from treatment, with nausea, dyspnoea and photosensitivity reaction among the most serious recorded.