FDA OKs lower weight limit for HIV drug dolutegravir in children, adolescents

SILVER SPRING, Md. — The Food and Drug Administration has approved a reduced weight limit for children and adolescents with HIV-1 being treated with dolutegravir, ViiV Healthcare announced Friday. 

 

The new weight limit for the 10- and 25-mg oral tablets is now at least 30 kg, down from at least 40 kg for patients ages 6 to less than 12 years. The drug will continue to be available in pediatric patients who are treatment naïve or previously treated who meet the weight limit and have not been treated with an integrase inhibitor. 

 

“From day one children and adolescents have been, and remain, a key focus in our drive to improve outcomes for people living with HIV,” ViiV chief scientific and medical officer Dr. John Pottage, Jr., said. “Through our research and development efforts, corporate social responsibility programmes, partnerships and access initiatives, we have made a difference for younger populations. This approval by the FDA provides more children and adolescents the option to be treated with dolutegravir in the US, and supports the global UNAIDS pediatric treatment target.”

 

Because of a voluntary license granted by ViiV to the Medicines Patent Pool and Aurobindo Pharma to allow the manufacture of generic dolutegravir without a royalty payment in 121 countries where 99% of the estimated 3.2 million children with HIV live, many more patients in this country will be eligible for treatment, the company said.