Merck's new HIV drug Pedro (Doravirin) was approved in China
Merck announced recently that its new HIV drug Pedro (doravirin tablets) has been officially approved by the NMPA for the treatment of human immunodeficiency virus type 1 (HIV-1) infected adults. This approval is based on a global phase III pivotal, randomized, multi-center, double-blind, active drug controlled clinical trial code-named DRIVE-FORWARD, which aims to evaluate the effect of dolavirin on patients without previous antiretroviral therapy Efficacy and safety of people infected with HIV-1.
The DRIVE-FORWARD trial reached its primary clinical endpoint. The data of the 48th and 96th weeks both showed that compared with the control group darunavir-ritonavir (DRV/r), it was at the same time with emtricitabine (FTC)/tenofovir disoproxil In the combination of ester (TDF) or abacavir (ABC)/lamivudine (3TC), doravirine (DOR) showed non-inferiority.
At the same time, the data from the DRIVE-FORWARD Phase III trial also showed significant clinical benefits for patient weight and blood lipid control.