Sovaldi combo sees CHMP green light
pharmafile | September 29, 2014 | News story | Sales and Marketing | CHMP, EU, Gilead, HCV, harvoni, hep C, sovaldi
The CHMP is recommending that Gilead’s new combination hepatitis C drug therapy Harvoni should be approved for use across the European Union for patients with certain types of the disease.
Harvoni works as a combined regime of several Gilead pills, namely via 90mg of once-daily NS5A inhibitor ledipasvir, and 400mg of nucleotide analog polymerase inhibitor Sovaldi (sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection in adults.
Sovaldi has become the quickest selling drug of all time since its launch at the start of the year, bringing in nearly $6 billion in sales in its first two quarters, although this trajectory is thought to be slowing down as new drugs appear on the horizon.
Its commercial success has come down to Sovaldi’s impressive study results, with around 90% of hep C patients expected to essentially be cured of the disease when using it.
A combination treatment could treat an even higher number of patients, although the costs of the drug – which is around £35,000 for Sovaldi alone in the UK – has remained a sticking point for pricing regulators.
The CHMP is not concerned with price tags however, and its positive opinion was adopted following an accelerated review procedure, which is reserved for medicinal products that are expected to be of ‘major public health interest’.
Its recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for use across the RU. This process typically takes around one to three months, meaning the treatment should be available by the end of the year.
Around nine million people in Europe are believed to be infected with the hepatitis C virus, a major cause of liver cancer and liver transplantation.
Ben Adams
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