Johnson & Johnson Expands Use of Prezcobix for Pediatric Patients in the US

Johnson & Johnson (J&J) seeks expanded use of its HIV-1 therapy, Prezcobix, for younger kids in the United States through a supplemental new drug application, according to reporting by Yahoo Finance.

Prezcobix is a combination tablet of darunavir and cobicistat used for the treatment of HIV-1 infection in adults and adolescents weighing at least 40 kg, with darunavir marketed as Prezista and cobicistat as Tybost. J&J also sells Symtuza, a once-daily single-tablet regimen (STR) based on darunavir.

The sNDA aims to approve Prezcobix for pediatric patients aged 6 and older who have no viral resistance mutations associated with darunavir, while a similar application has been submitted to the EMA for expanded use of Rezolsta in Europe as the brand name for Prezcobix. A collaboration between J&J and Gilead has resulted in the development of a weight-adjusted pediatric dose of darunavir and cobicistat in a new combination tablet for younger kids.

GSK, through its subsidiary ViiV Healthcare, is a key player in the HIV market alongside J&J and Gilead, primarily driven by their dolutegravir franchise. The company's HIV sales are expected to continue growing in the high single-digit to low double-digit range in 2024, fueled by strong demand for new, long-acting medicines like Cabenuva and Apretude.

Reference

Zach’s Equity Research. J&J (JNJ) seeks expanded use of HIV drug in US and Europe. Yahoo Finance. June 5, 2024. Accessed June 21, 2024. https://finance.yahoo.com/news/j-j-jnj-seeks-expanded-134700283.html