Posted by Michael Wonder on 05 Jun 2024
Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix
4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA seeking to expand the indication of Prezcobix (darunavir/cobicistat) to include the treatment of HIV-1 infection in younger children at least 6 years of age weighing at least 25 kg.
A parallel line extension application and type 2 variation application have also been submitted to the EMA for expanded paediatric use in Europe, where the product is marketed as Rezolsta.
