Please login to the form below

Not currently logged in
Email:
Password:

EU approval for Gilead’s hep C combo Harvoni

Another boost for the company’s fast-growing Sovaldi franchise
gilead-harvoni-ledipasvir-sofosbuvir

Gilead Sciences' rapidly growing hepatitis C business has gained another boost with the European approval of its combination treatment Harvoni.

The European Commission (EC) confirmed an earlier recommendation from the European Medicines Agency (EMA) for the use of the drug – a combination of Gilead's record-breaking Sovaldi and ledipasvir – to treat patients with chronic hepatitis C.

The drug is recommended for people with genotype 1 or 4 variations of hepatitis C regardless of whether they have had prior treatment or have cirrhosis. The recommended treatment duration is 12 or 24 weeks depending on prior treatment history and cirrhosis status.

An eight-week course of Harvoni may be also considered in non-cirrhotic treatment-naïve genotype 1 patients, while a combination of Harvoni and ribavirin may be considered in certain patients with genotypes 1, 3 and 4.

The approval is another major step for Gilead's Sovaldi franchise, which has been the most lucrative pharma launch of all time, achieving sales of $8.5bn during the first nine months of 2014.

Sovaldi's success has been primarily due to its more convenient treatment regimen as it allows patients to be treated without the need for weekly injectable interferon.

Harvoni extends this convenience further as the oral treatment eliminates the need for interferon and ribavirin, both of which can be difficult for patients to tolerate.

The combination treatment was approved in the US last month and expectations are high among the hepatitis C community as trials have demonstrated Harvoni can cure as many as 90% of patients within just eight weeks.

Competition has emerged though in the form of a combination of Janssen's NS3/4A protease inhibitor Olysio (simeprevir) and Sovaldi, which was approved by the US FDA earlier this month and also offers an all-oral, interferon and ribavirin-free option for hepatitis C patients.

20th November 2014

From: Sales

Share

Tags

Subscribe to our email news alerts

Featured jobs

PMHub

Add my company
Genesis Research

Genesis Research is an international HEOR and RWE research organization. A leader in evidence strategy, generation and communication, the company...

Latest intelligence

dementia
Alzheimer’s Research UK highlights socio-economic inequalities in dementia risk
The charity aims to improve the number of women participating in dementia research and grow awareness of dementia risk factors...
Data security
Concerns about data security are building a strong case for clinical mobility in EMEA
Electronic medical records have transformed the storage of sensitive information but how can the healthcare sector continue to protect patient and staff data?...
Mainimage2
The role of digital health technology tools in supporting medical adherence
How DHT-based digital interventions can help to support patients and improve adherence...