TaiMed's HIV biologic secures FDA nod
- The Food and Drug Administration announced Tuesday that it approved Trogarzo, an antiretroviral specifically for HIV patients who have been heavily treated and are resistant to multiple other drugs. Some of the patients in clinical trials failed on as many as 10 drugs previously.
- The win for TaiMed Biologics USA Corp. follows FDA's assignment of Orphan Drug, Fast Track, Priority Review, and Breakthrough Therapy designations.
- The approval was based on the use of Trogarzo in 292 heavily treated patients. The drug is given very 14 days via intravenous infusion by a trained medical professional in combination with other antiretrovirals.
While Trogarzo (ibalizumab-uiyk) will likely only ever be used in a small patient population due to its indication in heavily pretreated HIV patients, the approval points to another growing trend — the manufacturing of biologics in China. Trogarzo is a novel biologic with contract production from a China-based company, WuXi Biologics.
The approval follows a pre-license inspection of contract manufacturer WuXi Biologics’ facility — the first FDA inspection of its kind in China. In addition, the announcement marks the first report of an FDA approval of a sterile biologic product manufactured in China for use under a U.S. Investigational New Drug application.
WuXi and TaiMed's partnership on Trogarzo was first announced in 2012, and in 2013, WuXi reported it completed the first run of a 2,000 liter disposable bioreactor using an NS0 mouse myeloma cell line for the drug. As a result of its 2013 expansion, WuXi claimed it operated the largest biologics facility with disposable bioreactors in China.
The drug approval is a long time in the making. FDA granted ibalizumab Fast Track status in October 2003, a Phase 2a clinical trial was successfully completed in 2006, but then, there was a five-year gap before the Phase 2b trial concluded in 2011. TaiMed Biologics licensed ibalizumab from Roche AG's Genentech in 2007.
Capacity in China is growing at a significant rate, and WuXi may be seen as a threat to U.S.-based CDMOs and CMOs now that services like WuXi's are available to domestic companies. In fact, BioPlan Associates, Inc. Consultant Eric Langer told BioPharma Dive that there will be a “very substantial focus on GMP production for Western markets by Chinese drug developers."
Because it is the first mAb-based treatment approved for the treatment of HIV, its mechanism of action is different than most of the existing antiretroviral medications on the market, which work by inhibiting replication of the HIV virus. Trogarzo instead works by binding to the second extracellular domain of the CD4 receptor, preventing the virus from entering CD4+ immune cells.
- Food and Drug Administration Press release
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