ARTICLE | Regulation
Aug. 22 Quick Takes: European approval for Gilead’s twice-yearly HIV treatment
Plus EMA reviewing Travere’s sparsentan and Menarini’s elacestrant and updates from Pharvaris and more
August 23, 2022 12:31 AM UTC
The European Commission’s approval of Sunlenca lenacapavir from Gilead Sciences Inc. (NASDAQ:GILD) will give patients in Europe a twice-yearly treatment option for multi-drug-resistant HIV. FDA is set to decide whether to approve the capsid inhibitor, which has no known cross resistance to other existing drug classes, on Dec. 27.
Travere Therapeutics Inc. (NASDAQ:TVTX) said that EMA had accepted its conditional marketing authorization application for sparsentan to treat IgA nephropathy, with a decision expected in 2H23. FDA granted priority review to the company’s NDA for the dual angiotensin and endothelin receptor antagonist in May; the PDUFA date is Nov. 17. Travere has partnered with CSL Vifor, part of CSL Ltd. (ASX:CSL) in Europe. ...