Janssen’s hepatitis C drug Olysio cleared in EU

16 May 2014

Janssen-Cilag International, a subsidiary of US health care giant Johnson & Johnson (NYSE: JNJ), says that its next generation protease inhibitor (PI) Olysio (simeprevir) has been granted marketing authorisation by the European Commission for the treatment of adults with genotype 1 and 4chronic hepatitis C (CHC), in combination with other medicinal products, which includes:]

Patient population	Treatment	Duration
Patients with HCV genotype 1 or 4, regardless of prior treatment history and who are intolerant to or ineligible for interferon (IFN) treatment	Simeprevir + sofosbuvir, with or without ribavirin (RBV)	12 weeks
Treatment-naive and prior relapse patients with genotype 1 or 4 with or without cirrhosis and those co-infected with human immunodeficiency virus (HIV)	Simeprevir + pegylated interferon (PegIFN) + RBV	24 weeks Treatment with simeprevir must be initiated in combination with PegIFN + RBV and administered for 12 weeks, followed by an additional 12 weeks ofPegIFN + RBV
Prior non-responder patients (including partial and null responders) with HCV genotype 1 or 4 and those co-infected with HIV	Simeprevir + PegIFN + RBV	48 weeks Treatment with simeprevir must be initiated in combination with PegIFN + RBV and administered for 12 weeks, followed by an additional 36 weeks ofPegIFN + RBV

This marketing authorization represents a significant milestone in the development of new triple therapy hepatitis C (HCV) treatment options for genotype 1 and 4 patients. It also includes simeprevir as part of an all oral 12-week IFN-free direct-acting antiviral (DAA) regimen with or without RBV, in genotype 1 or 4 patients, who are intolerant to or ineligible for IFN treatment, the company noted.

This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Try before you buy

Free

7 day trial access

Take a Free Trial

All the news that moves the needle in pharma and biotech
Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
Receive The Pharma Letter daily news bulletin, free forever.

Become a subscriber

£820

Or £77 per month

Subscribe Now

Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
Daily roundup of key events in pharma and biotech.
Monthly in-depth briefings on Boardroom appointments and M&A news.
Choose from a cost-effective annual package or a flexible monthly subscription

The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK