(Yicai Global) March 7 -- The US Food and Drug Administration has approved a new type of antiretroviral medication for HIV patients who have tried multiple medications in the past, marking the first time a Chinese firm has received FDA approval for a biological product.
Jiangsu-based Wuxi Biologics Inc. manufactured Trogarzo, a HIV-1 treatment on behalf of Taiwan-based TaiMed Biologics Inc., which was granted the FDA approval, it said in a statement.
"Trogarzo is the first drug in a new class of antiretroviral medications that can provide significant benefit to patients who have run out of HIV treatment options. New treatment options may be able to improve their outcomes," said Jeff Murray, a director at the FDA.
The FDA fast-tracked the drug's application and review due to its clinical efficacy.
The drug is mainly aimed at patients with multidrug-resistant HIV, or AIDS patients, whose infections cannot be effectively treated with currently available therapies. Trogarzo is administered intravenously once every 14 days and used in combination with other antiretroviral medications.
"Though most HIV patients can be treated using a combination of therapies, some still have multidrug-resistant HIV, putting them at a higher risk of complications and death," added Murray.
Trogarzo safety and effectiveness were verified in a clinical trial of 40 patients who suffer multidrug-resistant HIV. The majority of these patients experienced a substantial decrease in their HIV-RNA levels within one week after receiving the drug treatment. Some 43 percent continued to experience HIV-RNA inhibition after 24 weeks of taking Trogarzo.
Wuxi Biologics Inc., an affiliate of Wuxi AppTec Inc., provides end-to-end solutions for biologics discovery, development and manufacturing.