AbbVie’s (ABBV) all-oral, short-course, interferon-free hepatitis C virus (HCV) treatment is now approved in the EU under the trade name Viekirax + Exviera. The treatment can be used with or without ribavirin (RBV) in patients with genotype 1 (GT1) chronic HCV infection, including those with compensated liver cirrhosis.
EU approval was largely expected as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had issued a positive opinion late last year. With Viekirax + Exviera getting EU approval, competition in the HCV market in the EU will increase.
We note that AbbVie’s HCV treatment had gained FDA approval in late Dec 2014 under the trade name Viekira Pak. Shortly after gaining approval, pharmacy benefit manager (PBM) Express Scripts (ESRX) announced its decision to add Viekira Pak to its formulary and offer it as an exclusive option for genotype 1 HCV patients, starting Jan 1, 2015 (Read more: Express Scripts Picks AbbVie's Hepatitis C Drug).
The PBM also announced that HCV treatments like Olysio and Gilead's (GILD) Sovaldi and Harvoni would be removed from the National Preferred Formulary. While high rates of response and tolerability coupled with low discontinuation rates should help Viekira Pak gain share, pricing will play an equally important role.
In fact, a lot is being said about the HCV pricing battle between AbbVie and Gilead with Gilead signing up with PBMs and health care benefit companies for Sovaldi and Harvoni.
AbbVie is scheduled to report fourth quarter and full year 2014 results on Jan 30. We expect investor focus to remain on the company’s strategy for its HCV treatment and sales expectations for 2015.
AbbVie is a Zacks Rank #2 (Buy) stock. A better-ranked stock in the health care sector is Amgen (AMGN) with a Zacks Rank #1 (Strong Buy).
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