Merck's new HIV drug Pedro (Doravirin) was approved in China
2020-12-08
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.
