Please login to the form below

Not currently logged in
Email:
Password:

Gilead’s hep C combination Harvoni recommended for EU approval

CHMP backs combination of Sovaldi and ledipasvir

Gilead Sciences

European regulatory advisors have recommended the approval of Gilead's chronic hepatitis C (HCV) treatment Harvoni.

Harvoni, which combines Gilead's blockbuster Sovaldi (sofosbuvir) and ledipasvir, blocks the action of proteins that are essential for HCV to replicate – the protein NS5B for Sovaldi and NS5A for ledipasvir.

New regimens such could allow the cure of patients with chronic HCV without the need for treatments involving interferons, medicines, which are associated with poor tolerability and potentially serious side effects that rule out such treatment in a considerable proportion of patients.

The EMA's Committee for Medicinal Products for Human Use (CHMP) backed the use of Harvoni, which was evaluated under the Agency's accelerated assessment programme, putting it on course for European approval before the end of the year.

The decision was based on phase III data evaluating 8, 12 or 24 weeks of treatment with Harvoni, with or without ribavirin, among nearly 2,000 genotype 1 HCV patients with compensated liver disease.

The trials, which included cirrhotic and non-cirrhotic patients who were new to HCV treatment, showed high efficacy against genotypes 1, 3 and 4, including patients post-transplant. The most common side effects are fatigue and headache.

HCV affects between 0.4% and 3.5% of the population of EU member states, some nine million people, and is the most common single cause of liver transplantations in the EU.

Over the past few months, the CHMP has recommended marketing authorisations for three other medicines for the treatment of HCV - Sovaldi, J&J's Olysio and BMS' Daklinza.

Article by
Kirstie Pickering

30th September 2014

From: Sales, Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Real Science Communications

Real Science Communications is a scientific centre of excellence, infusing credibility and scientific rigour into the conversations around health and...

Latest intelligence

women
Advancing women in healthcare
Fostering the next generation of leaders...
The Challenges Of UX In Healthcare: Technology To Change Lives
Blue Latitude Health Director and Head of Customer Experience Elisa Del Galdo explores the latest digital healthcare trends and reveals the innovations changing the sector today....
It’s all about patient outcomes… right?
Lessons from history: a design thinking perspective...

Infographics