The European Medicines Agency (EMA) has validated Gilead Sciences’ marketing authorisation application (MAA) for investigational Chronic Hepatitis C Therapy Sofosbuvir / Velpatasvir / Voxilaprevir (SOF / VEL / VOX).

The once-daily, single tablet regimen of sofosbuvir 400mg, velpatasvir 100mg and voxilaprevir 100mg (SOF / VEL / VOX) will be used to treat chronic hepatitis C virus (HCV)-infected patients.

The agency is currently assessing the application.

Gilead Sciences executive vice-president of research and development and chief scientific officer Norbert Bischofberger said: “Direct-acting antiviral treatments have transformed our ability to treat hepatitis C, however, for some patients who have failed to achieve a cure with these regimens, effective and well-tolerated therapies are still needed.

“The submission of this application reflects our continued commitment to provide treatment options for this life-threatening disease to as many patients as possible, including those who have failed previous direct-acting antiviral therapy, in Europe and around the world.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The MAA is supported by data from POLARIS-1 and POLARIS-4 Phase III studies, as part of which 12 weeks of the fixed-dose combination was evaluated in direct-acting antiviral (DAA)-experienced patients with hepatitis C genotypes 1-6.

Those who failed prior treatment with an NS5A inhibitor-containing regimen were also evaluated as part of the studies.

The primary efficacy endpoint of SVR12 was achieved by 97% of patients treated with SOF / VEL / VOX across the studies.

"The primary efficacy endpoint of SVR12 was achieved by 97% of patients treated with SOF / VEL / VOX across the studies."

The MAA also includes data from POLARIS-2 and POLARIS-3 additional phase III studies, which evaluated eight weeks of SOF / VEL / VOX in 611 DAA-naïve patients with genotypes 1-6.

In POLARIS-3, 96% of patients with genotype 3 infection and cirrhosis treated with SOF / VEL / VOX achieved the primary efficacy endpoint.

Patients who received SOF / VEL / VOX were found to have the most common adverse events such as headache, fatigue, diarrhoea and nausea.

The EMA will review SOF / VEL / VOX under the centralised licencing procedure for all 28 member states of the European Union, Norway and Iceland.


Image: Hepatitis C virus (HCV). Photo: courtesy of BruceBlaus.