BioCentury
ARTICLE | Clinical News

TaiMed's ibalizumab gets FDA Priority Review for HIV

August 16, 2017 8:07 PM UTC

TaiMed Biologics Inc. (TPEx:4147) said FDA accepted and granted Priority Review to a BLA for ibalizumab (TMB-355) to treat multidrug-resistant HIV-1 infection. Its PDUFA date is Jan. 3, 2018. TaiMed said ibalizumab does not require daily dosing and would be the first antiretroviral treatment with a new mechanism of action approved by FDA in nearly a decade.

In 2014, ibalizumab became the first biologic manufactured in China to receive FDA clearance for U.S. use under an IND (see BioCentury, May 12, 2014)...