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.
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(Reporting by Ben Hirschler; Editing by Sophie Walker)
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