AbbVie says hepatitis C
regimen gets nod for FDA priority review
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[June 14, 2014]
(Reuters) - U.S. regulators have granted priority review
for AbbVie Inc's experimental all-oral regimen for
patients infected with the most common genotype of
hepatitis C virus, the company said on Friday.
The priority review means the Food and Drug Administration will
likely decide within six months whether to approve the regimen,
which was submitted to the agency on April 21.
AbbVie said it had submitted in May marketing applications for
regulatory approval in the European Union.
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 Inc, which launched breakthrough hepatitis C drug
Sovaldi in December, is slated to hear from the FDA on its
application for an all-oral regimen - which combines Sovaldi with
experimental NS5A inhibitor ledipasvir - by early October.
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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 Deena Beasley; Editing by Diane Craft)
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