Merck announced that the FDA approved supplemental New Drug Applications (sNDAs) for Pifeltro (in combination with other antiretroviral agents) that...
Merck has announced that the FDA has accepted for review supplemental New Drug Applications (sNDAs) for Pifeltro and Delstrigo. The...
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation...
Merck & Co. Inc. has announced that the FDA has approved two new HIV-1 medicines, Delstrigo and Pifeltro (doravirine) (MK...
Merck Inc announced positive top-line results from two pivotal Phase III trials of the investigational, once-daily oral fixed dose combination pill of MK 8591 + Pifeltro (islatravir + doravirine) (DOR/ISL) in adults with HIV-1 infection who are virologically suppressed on different antiretroviral therapy regimens (ART; ILLUMINATE SWITCH A) or bictegravir/emtricitabine/tenofovir (BIC/FTC/TAF; ILLUMINATE SWITCH B).
Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of resistance to the NNRTI class (see sections 4.4 and 5.1).
To establish a new treatment option for treatment-naïve participants with HIV-1, the efficacy and safety of doravirine will be determined relative to a protease inhibitor (PI).