FDA gives Merck the green light for two new HIV drugs
Merck has received the blessing from the Food and Drug Administration for two new HIV medicines, the company announced recently. Delstrigo is a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg) and tenofovir disoproxil fumarate (300 mg); and Pifeltro (doravirine, 100 mg) is a new non-nucleoside reverse transcriptase inhibitor indicated to be administered in combination with other antiretroviral medicines.
Both drugs are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food.
Delstrigo contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B infection. Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS, the company said.
“As part of Merck’s 30-year commitment to the care of people with HIV, we are pleased to now bring forward these two new antiretroviral treatment options, Delstrigo and Pifeltro, which we believe offer a compelling clinical profile for clinicians and people living with HIV,” Merck Research Laboratories global clinical development vice president and therapeutic area head of infectious diseases, George Hanna said. “We are thankful to the researchers as well as those living with HIV and their communities for the collaboration that made today’s approval possible.”
Both drugs are indicated for the treatment of HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food.
Delstrigo contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B infection. Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS, the company said.
“As part of Merck’s 30-year commitment to the care of people with HIV, we are pleased to now bring forward these two new antiretroviral treatment options, Delstrigo and Pifeltro, which we believe offer a compelling clinical profile for clinicians and people living with HIV,” Merck Research Laboratories global clinical development vice president and therapeutic area head of infectious diseases, George Hanna said. “We are thankful to the researchers as well as those living with HIV and their communities for the collaboration that made today’s approval possible.”