AbbVie Inc. ABBV announced a series of regulatory/pipeline updates. The company’s Viekirax has been approved by the Japanese Ministry of Health, Labour and Welfare as a new interferon and ribavirin-free treatment option for patients suffering from chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated liver cirrhosis. Viekirax (with or without ribavirin) is already approved in Europe in combination with Exviera for the treatment of GT1 chronic HCV patients, including those with compensated liver cirrhosis, HIV-1 co-infection, patients on opioid substitution therapy and liver transplant recipients. Additionally, Viekirax is approved in the EU for use with ribavirin in genotype 4 chronic hepatitis C patients.
Additionally, the company announced positive results from two double-blind, placebo-controlled, dose-ranging phase II studies (BALANCE-I and BALANCE-II) on its rheumatoid arthritis candidate, ABT-494. Both studies evaluated patients suffering from moderate-to-severe rheumatoid arthritis, who responded inadequately to prior anti-TNF (TNF-IR) or methotrexate (MTX-IR) treatment, respectively. The primary endpoint of both studies was the percentage of patients achieving an ACR20 response after 12 weeks of treatment.
AbbVie stated that both studies achieved impressive levels of ACR20 at week 12 across all doses of ABT-494, except the lowest dose in the BALANCE-II study. In the TNF-inadequate responder population, ACR20 responses were up to 73%, while that in the MTX-inadequate responder population was up to 82%. The company intends to advance the once-daily formulation of ABT-494 to phase III studies for the treatment of rheumatoid arthritis by 2015 end.
AbbVie is also evaluating ABT-494 in a phase II study for the treatment of Crohn's disease.
Meanwhile, following a thorough review of available data, AbbVie decided not to exercise its right to in-license a JAK1 inhibitor, filgotinib, from Galapagos NV GLPG and terminated its agreement with the company for the development of filgotinib. Galapagos will advance filgotinib to phase III development for rheumatoid arthritis in early 2016.
AbbVie currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the health care sector are Eli Lilly and Company LLY and Abbott Laboratories ABT. Both carry a Zacks Rank #2 (Buy).
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