J&J HIV therapy approved by the US FDA for use in children

A HIV antiretroviral therapy, EDURANT®, from Johnson & Johnson has been granted approval from the US FDA for use in children with HIV-1 from the age of two. 

Now, the US FDA has approved the antiretroviral treatment EDURANT® PED (rilpivirine) from Johnson & Johnson for children. The therapy is used to HIV-1 in combination with other antiretroviral therapies in treatment naïve children, weighing between 14 and 25 kg. 

J&J have pioneered HIV/AIDS treatment and aid since 1985, working with several charities and bodies to help those suffering across the world and give access to a range of treatment options that could help them. EDURANT® was initially approved in 2011, and after much testing and research J&J are pleased to announce the approval in paediatric patients with the disease. 

“Decades of experience with the global HIV epidemic have made it clear that new and improved treatment options are needed to support the diverse population of people living with HIV on their treatment journey,” stated Penny Heaton, MD, Global Therapeutic Area Head, Infectious Diseases and Vaccines at Johnson & Johnson. “While the population of young children living with HIV is small, additional treatment options remain key to ensuring that each person living with HIV can be matched to a treatment regimen that is right for them.”

The approval comes after results from two clinical trials were released from J&J. The PAINT and PICTURE studies looked at paediatric patients, who were treated with rilpivirine in conjunction with other antiretrovirals. The results of the studies demonstrated that rilpivirine was effective in suppressing the HIV-1 virus in patients with HIV-1 RNA <100,000 copies/mL.

The dosing has been updated to include not only a 25 mg oral dosage (EDURANT®) but also a weight adjusted oral tablet of 2.5 mg, which is more suitable for children. 

Source:

Johnson & Johnson. U.S. FDA Approves EDURANT® PED (rilpivirine) for Certain Pediatric Patients Living with HIV-1. [Date accessed]. www.jnj.com/media-center/press-releases/u-s-fda-approves-edurant-ped-rilpivirine-for-certain-pediatric-patients-living-with-hiv-1