Janssen submits new drug application for HIV therapy

|By:, SA News Editor

J&J's (JNJ) Janssen unit files an NDA a once-daily antiretroviral combo tablet containing the protease inhibitor darunavir and cobicistat an investigational pharmacokinetic enhancer developed by Gilead Sciences (GILD).

If approved, the product will be marketed under a new brand name. It will eliminate the need to take a separate boosting agent (ritonavir) with darunavir, the most-prescribed HIV protease inhibitor in the U.S.