WHO has issued Macleods Pharmaceuticals Ltd. certificate of prequalification for the drug dolutegravir 10 mg. It is intended for the treatment of HIV in children as part of complex therapy.
This is the first 10 mg dose that has passed the WHO retraining procedure, which evaluates the quality, safety and effectiveness of medicines. In addition, a similar dosage of 10 mg from Mylan has a certificate of prior approval from the US Food and Drug Administration (FDA), according to the Coalition for Readiness.
In 2014, the Medical Patent Pool and ViiV signed a license agreement for dolutegravir. And in last April, a special agreement was signed on four countries: Azerbaijan, Belarus, Kazakhstan and Malaysia. Three companies became co-licensees: Viatris (Mylan), Hetero and SUN. And Macleods is a sublicensee under a standard agreement.
Dolutegravir is an antiviral drug for the treatment of second-generation integrase inhibitors. Back in 2019, the WHO recommended this drug for the treatment of HIV as the best first and second line treatment for all groups, including pregnant women and women of childbearing age.