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Prezista gets extended EU licence
04 Dec 2008
Regulatory Affairs
HIV drug Prezista (darunavir) has been granted an expanded marketing authorisation in the EU, Tibotec Pharmaceuticals has announced.
The company stated that the European commission has broadened the indication for the protease inhibitor to enable it to be used in combination with ritonavir and other antiretroviral medicines in treatment-experienced adult patients with HIV-1 infection.
In making its application for extended marketing approval, Tibotec had submitted a 48-week analysis of data from the phase-three Titan trial.
"The availability of darunavir for the full spectrum of treatment-experienced patients in the EU provides caregivers and patients with important additional options to manage HIV," said Roger Pomerantz, president of Tibotec research and development.
He added that his company will continue in its efforts to develop more innovative treatments for HIV.
Meanwhile Tibotec has struck a licensing deal with Emcure Pharmaceuticals to distribute darunavir in India.
Tibotec, which has been working to gain registration of the medicine in the country, stated that Emcure's country-wide distribution capability was an important factor in the deal.
