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AbbVie closes in on US approval of all-oral hepatitis C regimen

FDA grants priority review to company’s protease inhibitor ABT-450 regimen

The US FDA has granted priority review to AbbVie's all-oral regimen for the treatment of adult patients with hepatitis C virus (HCV) infection, setting up possible approval before the end of the year. 

The regimen consists of the protease inhibitor ABT-450 boosted by ritonavir and co-formulated with the polymerase inhibitor dasabuvir, alongside NS5A inhibitor ombitasvir, and is among a series of new therapies for HCV coming through the late-stage pipeline. 

AbbVie's candidate therapy is dosed twice daily and can be administered with or without ribavirin, a long-standing oral therapy for HCV. It was awarded breakthrough status by the FDA last year and has been submitted for approval for use in for patients with the most common chronic genotype 1 (GT1) form of the disease. 

The regimen was submitted for approval in the EU last month, where it has also been awarded priority review status.

The aim is to effectively treat HCV in weeks rather than the several months of therapy required using earlier regimens, based on injections of pegylated interferon alfa and oral ribavirin, which are hard for patients to tolerate. 

Gilead Sciences - which blew apart the HCV market with the launch of its NS5B polymerase inhibitor  Sovaldi (sofosbuvir) last December - is also vying to bring an all-oral regimen to market in the US and is shaping up to be a tough rival for AbbVie and other HCV hopefuls such as Merck & Co, Bristol-Myers Squibb and Johnson & Johnson.  

Sovaldi has smashed all records for a new product launch in the pharmaceutical industry, racking up sales of $2.3bn in the first quarter of 2014 thanks to pent-up demand and a hefty $84,000 per course price tag that some critics have labelled as exploitative

Gilead is waiting to hear from the FDA on an all-oral regimen that combines Sovaldi with its NS5A inhibitor ledipasvir, with a verdict expected in October, around the same time that the review of AbbVie's combination could be concluded. 

AbbVie's US marketing application was submitted in April and is based on six phase III studies involving around 2,300 GT1 patients in more than 25 countries. 

The priority review for AbbVie's regimen is a boost for Enanta Pharmaceuticals, which co-developed the therapy with AbbVie and says it received $40m in milestone payments from AbbVie in the first quarter, in part resulting from the FDA filing.

16th June 2014

From: Sales

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