Europe - BMS' Sustiva MA withdrawn in HIV

BMS has withdrawn its MA for Sustiva (efvirenz) in HIV. The EC Decision, dated 1 Feruary 2024, was a result of BMS' request.

No other information related to reasons for the withdrawal were provided.

The approved indication was the following: 

"Sustiva is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 months of age and older and weighing at least 3.5 kg.

Sustiva has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens. Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing Sustiva."