LONDON, June 17 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
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
(Reporting by Ben Hirschler; Editing by Sophie Walker)