LONDON, June 17 (Reuters) - European regulators have validated AbbVie’s application for an experimental all-oral regimen for patients infected with the most common genotype of hepatitis C virus and the therapy is now under accelerated assessment.
The U.S. drugmaker said on Tuesday the move by the European Medicines Agency meant that, if approved, its regimen could be available in the European Union in the first quarter of 2015. U.S. regulators have also granted the product priority review.
AbbVie’s regimen consists of protease inhibitor ABT-450, boosted by a widely used antiviral called ritonavir, combined with polymerase inhibitor dasabuvir, and NS5A inhibitor ombitasvir with or without the older antiviral drug ribavirin.
Gilead Sciences, which launched breakthrough hepatitis C drug Sovaldi in December, is slated to hear from U.S. regulators on its application for an all-oral regimen - which combines Sovaldi with experimental NS5A inhibitor ledipasvir - by early October.
Prior to Sovaldi’s approval, hepatitis C needed to be treated for at least six months with a combination of pills and injections that could cause severe flu-like symptoms and other side effects that led many people to avoid or discontinue treatment. (Reporting by Ben Hirschler; Editing by Sophie Walker)