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AbbVie's hep C combo gets priority review in Europe

EMA to fast track drug for use in hard-to-treat genotype 1 strain of HCV

AbbVie has filed for approval of its interferon-free regimen for hepatitis C virus (HCV) in the EU and says the European Medicines Agency has agreed to fast-track its review.

The all-oral therapy is based on the protease inhibitors ABT-450/ritonavir, which are co-formulated with NS5A inhibitor ombitasvir (ABT-267) in a once-daily dose, and given alongside the NS5B RNA polymerase inhibitor dasabuvir (ABT-333) which is dosed twice-daily.

AbbVie is seeking approval of the therapy for patients with the hard-to-treat genotype 1 (GT1) strain of HCV, and recently reported encouraging phase III data showing that 92 per cent of GT1 patients as well as established liver disease had a sustained virologic response (SVR) at 12 weeks with the cocktail.

GT1 is the most common HCV genotype worldwide and has two subtypes, 1a and 1b, which are responsible for the vast majority of the 160m infections worldwide. GT 1b infection is the most prevalent form, found manly in Europe and Asia, while GT 1a infection is common in North America.

While a swathe of oral HCV therapies have reached or are nearing the market, AbbVie has largely taken its own path to developing an alternative to injectable interferon-based regimens, eschewing studies combining own drugs with candidates from other drugmakers.

Its main rival in the HCV sector is Gilead Sciences, whose NS5B polymerase inhibitor Sovaldi (sofosbuvir) has racked up impressive sales since its debut in the US last December thanks to premium pricing.

Sovaldi brought in a massive $2.27bn in the first quarter of this year, with $2.1bn of that coming from the US, and its $84,000-per-course price tag is already raising hackles among US lawmakers. Meanwhile, Gilead has also filed for a fixed-dose combination of the drug alongside NS5A inhibitor ledipasvir in the US and Europe.

Johnson & Johnson recently entered the fray following approval of its protease inhibitor Olysio (simeprevir) while other companies - including Boehringer Ingelheim and Merck & Co - also have candidates in late-stage development and the HCV market is looking increasingly competitive.

AbbVie chief executive Richard Gonzalez told investors last month that the company's regimen has a competitive profile, offering high cure rates and good tolerability as well as convenient dosing regimen.

This is " a large market and [will] stay a large market for a long period … because of the clinical capacity and the triaging of patients over time," he said.

"Physicians and payors would want multiple options in the marketplace," he continued, adding: "We are going to be an early entry into the marketplace and provide an alternative to the other competitive offerings."


8th May 2014

From: Sales

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