Shionogi, Viiv Healthcare sales and marketing update

Late last year, ViiV and Shionogi partnered to co-promote ViiV's dolutegravir in Japan. In December, ViiV submitted a regulatory application to Japan's Ministry of Health, Labor and Welfare for the HIV integrase inhibitor to treat HIV infection. The companies could not be reached for details.

In November, EMA's CHMP issued a positive opinion recommending approval of an MAA from ViiV for Tivicay dolutegravir in combination with other antiretroviral agents to treat HIV infection in patients ages 12 years and over. In August, FDA approved an NDA for Tivicay to treat HIV infection in combination with other antiretroviral agents in treatment-naïve and treatment-experienced patients ages 12 years and over. The drug had Priority Review and was the first from ViiV's pipeline to be approved. Dolutegravir is also approved in Canada to treat HIV infection in patients ages 12 years and over (see BioCentury, Aug. 19, 2013 & Nov. 25, 2013). ...