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Two new hepatitis C therapies fast-tracked in Europe

EMA speeds review process for Gilead and AbbVie treatments

European Union EMA 

Two drug combinations from Gilead and AbbVie that could improve treatment of chronic hepatitis C have been granted accelerated review in the EU.

Gilead's application is for a three drug combination of NS5B polymerase inhibitor sofosbuvir, NS5A inhibitor velpatasvir and pan-genotypic protease inhibitor voxilaprevir – given over 12 weeks – that could achieve a cure for chronic hepatitis C virus (HCV) patients who have failed other regimens. 

The new directly-acting antivirals can now cure more than 90% of people with all hepatitis C virus (HCV) genotypes, but there is still room for better options for the most difficult-to-treat people.

Sofosbuvir and velpatasvir are the two active ingredients in Gilead's recently-approved two-drug HCV combination Epclusa, as a successor to its massively successful Harvoni (sofosbuvir/ledipasvir) but with activity against all HCV genotypes (1-6). The regimen is dosed as a single tablet once a day.

Meanwhile, AbbVie has filed for approval of a two drug formulation of NS3/4A protease inhibitor glecaprevir and NS5A inhibitor pibrentasvir for the treatment of all major HCV genotypes which can be given over just eight weeks in patients without cirrhosis. 

The new treatment also provides an alternative 12-week regimen for HCV patients with cirrhosis, said AbbVie. It is dosed once daily as three oral tablets and is being billed as a rival to Epclusa, which is dosed over 12 weeks in all patients.

Accelerated assessment means that both new treatments could be approved for marketing early in the second half of the year.

The two new drug combinations will enter a rapidly evolving HCV treatment market. Gilead's market leading Harvoni and Sovaldi (sofosbuvir) have been taking a beating in the face of increased competition – from AbbVie's portfolio as well as other new products such as Merck & Co's Zepatier (elbasvir/grazoprevir) – as well as pricing pressure. 

Gilead reported that sales of its franchise fell by 30% to $3.3bn in the third-quarter of 2016. Analysts at Leerink have previously predicted that combined sales of Harvoni, Sovaldi and Epclusa will be $2.5bn a year after 2017 and decline to $1.7bn by 2020.

Article by
Phil Taylor

24th January 2017

From: Regulatory



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