USFDA approves Taiwan, China's HIV drug

A biologically-based alternative HIV treatment developed in China's Taiwan, China Region and manufactured in China has won approval from the U.S. Food and Drug Administration (FDA), becoming the first such made-in-China drug to receive such approval.

TaiMed Biologics of Taiwan, China received US marketing approval for a novel HIV-1 treatment aimed at multi-drug-resistant patients. China's WuXi Biologics manufactures Trogarz (ibalizumab) for TaiMed, and Montreal's Theratechnologies owns US rights to the drug.

Trogarzo, with its unique mechanism, is the first new HIV treatment in ten years. The drug will be given as a second-line treatment to patients who are failing normal antiretroviral treatments. Trogarzo is administered by injection on a bi-weekly schedule. The wholesale price is said to be $118,000, presumably for a year. 

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