Bristol-Myers gets added indication from US FDA for Sustiva; signs second deal with Ambrx

US pharma major Bristol-Myers Squibb (NYSE: BMY) says that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5kg.

This approval offers a once-daily option as part of a regimen for this population and includes a “capsule sprinkle” administration method for patients who cannot swallow capsules or tablets, according to B-MS. Sustiva is already a blockbuster drug for B-MS, generating first-quarter 2013 sales of $387 million.

Sustiva is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that was originally approved in the USA in 1998 to treat HIV-1 infected children three years of age or older and weighing at least 10kg.