$ABBV HCV Treatment Granted Priority Review in Japan – Analyst Blog

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AbbVie’s HCV Treatment Granted Priority Review in Japan – Analyst Blog

AbbVie ABBV announced that its experimental hepatitis C virus (HCV) treatment was granted priority review in Japan.

AbbVie’s all-oral, ribavirin and interferon free, 12-week, two direct-acting antiviral treatment comprises a fixed dose of paritaprevir/ritonavir in combination with ombitasvir, dosed once daily. The company is looking to get the combination approved for the treatment of patients with genotype 1 (GT1) chronic HCV infection.

In Feb 2015, AbbVie had filed a new drug application with the Japanese Ministry of Health, Labour and Welfare for the HCV treatment.

We note that AbbVie’s three-drug HCV regimen, Viekira Pak and Viekirax + Exviera has already gained approval in the U.S. (Dec 2014) and EU (Jan 2015). AbbVie’s two-drug direct-acting HCV regimen also has a good chance of gaining approval based on high rates of response and low discontinuation rates.

We remind investors that pharmacy benefit manager (PBM), Express Scripts ESRX, has added AbbVie’s Viekira Pak to its formulary offering it as an exclusive option for GT1 HCV patients from Jan 1, 2015. Express Scripts’ decision to choose lower-priced Viekira Pak over other expensive HCV drugs like Gilead’s GILD Sovaldi and Harvoni has led to intense pricing competition in the HCV market.

Several other companies are also looking to bring their shorter duration HCV treatments to the market. We expect the HCV market and pricing competition to remain in focus for the rest of 2015.

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