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 이성욱 ( 2014-06-17 10:46:07 , Hit : 1493
 AbbVie says hepatitis C regimen gets nod for FDA priority review


Fri Jun 13, 2014 5:02pm EDT

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(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.

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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