Taiwanese company wins FDA approval for HIV treatment with new mechanism of action

Electromicrograph showing an HIV-infected T cell in blue and yellow
The FDA approved TaiMed Biologics and partner Theratechnologies’ Trogarzo, the first HIV therapy with a novel mechanism of action in more than 10 years. (NIAID)

While several classes of drugs have made HIV a manageable disease, there’s a small group of patients who develop resistance against multiple treatments. Now, the FDA has approved a Taiwanese company's new drug that can address that resistance. 

Developed by TaiMed Biologics, Trogarzo (ibalizumab-uiyk) is the first HIV therapy with a novel mechanism of action in more than 10 years. A humanized monoclonal antibody, Trogarzo blocks the HIV virus from infecting host cells by binding to extracellular domain 2 of the CD4+ receptor, a site different from other antiretrovirals currently on the market. It is given intravenously once every 14 days and used in combination with other antiretrovirals.

“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,” said Jeff Murray, M.D., deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research.

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The approval came after a phase 3 trial on 40 multidrug-resistant HIV-1 patients, in which 33 (82.5%) of them achieved the primary endpoint of a viral load reduction of at least 70% following a seven-day treatment period. At the end of the trial (24 weeks of treatment), the viral load was undetectable in 43% of study participants.

About 20,000 to 25,000 patients in the U.S. currently live with MDR HIV-1, according to a recent analysis by TaiMed. The Taiwan-based company said it received positive views from U.S. payers toward a new drug for these difficult-to-treat patients.

RELATED: Gilead strikes back at GSK with positive HIV head-to-head trial data for expected blockbuster

The agency handed out the approval from a priority review pathway, and it had previously also granted the drug fast track, breakthrough therapy and orphan drug designations. The last one means Trogarzo has 12 years of marketing exclusivity.

Canadian pharma Theratechnologies gained exclusive marketing and distribution rights for Trogarzo in North America through an agreement with TaiMed in 2016. TaiMed got $1 million in upfront payment at the time and will get another $1 million upon the launch of the drug. The deal also tied several million dollars to certain conditions at commercial launch. Additional payments are pegged to annual sales, going all the way up to $100 million if the drug reaches $1 billion in sales.

Under a second deal signed in 2017, Theratechnologies also holds rights to the drug in the European territory, including the EU, Israel, Norway, Russia and Switzerland.

TaiMed will still be responsible for manufacturing, and that’s done by WuXi Biologics. A prelicense inspection of the facility for the production of Trogarzo makes WuXi the first and now still the only Chinese company to receive an FDA clearance for biological products.

All three companies involved saw their shares jumped at the news: nearly 10% for TaiMed in Taipei, more than 27% for Theratechnologies in Toronto, and more than 5% for WuXi Biologics in Hong Kong.