The U.S. Food and Drug Administration has approved two HIV oral drugs produced by Merck & Co Inc, nearly two months ahead of schedule the company said on Thursday.
The drugs have been approved to treat adults with the most common strain of the virus, HIV-1, and target patients who have received no prior antiretroviral treatment, Merck said.
Delstrigo, a once-a-day combination tablet, has been approved with a boxed warning, the agency’s strictest, to flag risk of worsening hepatitis B infection.
Pifeltro, the second drug, is an oral medicine to be administered in combination with other antiretrovirals, Merck said.
The company also said it expects to stock both the treatments through wholesalers within a month.