FDA gives a ‘go-ahead’ for Made-in-China HIV drug Trogarzo

The U.S. Food and Drug Administration has apparently given a green signal for the use of Trogarzo, a drug used in alternative HIV therapy for adult patients. Also referred to as Ibalizumab-uiyk, this drug has been developed by a Taiwanese firm TaiMed Biologics and manufactured in China in association with WuXi Biologics.

Reliable sources claim that Trogarzo is the first of its kind across the new class of antiretroviral medicines that can provide relief to the patients treated earlier with conventional drugs without any success. According to the U.S. drug authority, the new medicine was proved to be safe & effective in the clinical tests conducted by TaiMed on forty patients, who had experienced substantial improvement in a week after being treated with Trogarzo.

TaiMed stated that after 24 weeks of treating patients with both Trogarzo and other antiretroviral medicines, it was found that 43% of the patients had developed HIV RNA suppression. FDA declared that this medicine will be prescribed for a small percentage of patients (only around one percent), who have been treated for HIV infections through multidrug methodologies, but without any positive outcomes.

Jeff Murray, deputy director of the Antiviral Products division in the FDA’s Center for drug evaluation & research, remarked that while most of the HIV infected persons can be successfully treated by combining two or many antiretroviral medicines, a minor section of patients are resistant to multidrug therapy. He further added that these individuals will have limited treatment alternatives, thereby putting them at a higher risk of acquiring HIV-related complications.

Reports claim that TaiMed’s drug application received a fast-track approval, priority review, and breakthrough treatment designation from the FDA. Trogarzo was also granted the “orphan drug” status from the U.S. drug authority for promoting the discovery of new medicines with limited market potential.