FDA nod for expanded indication for two Merck HIV treatments

US pharma giant Merck & Co (NYSE: MRK) says that the US Food and Drug Administration approved supplemental New Drug Applications (sNDAs) for Pifeltro (in combination with other antiretroviral agents) and Delstrigo (as a complete regimen) that expand their indications to include adult patients with HIV-1 infection who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to Pifeltro or the individual components of Delstrigo.

Merck’s shares gained 1.42% to $84.16 following the announcement on Friday.

Analysts at  GlobalData have previously predicted peak sales in 2023 of Delstrigo will reach $369 million in the top seven pharma markets, and Pifeltro $144 million.