Regulation

Jan. 21 Quick Takes: FDA approves ViiV’s long-acting HIV therapy; plus Menarini, Incyte, Moderna, Genentech   

FDA approved ViiV Healthcare Ltd.’s Cabenuva, the first extended-release injectable regimen to treat HIV-1 infection in adults. The drug comes as a co-pack with two injectable drugs — ViiV’s cabotegravir and rilpivirine from the Janssen unit of Johnson & Johnson (NYSE:JNJ) — dosed once-monthly. ViiV is majority owned by GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), Pfizer Inc. (NYSE:PFE) and Shionogi & Co. Ltd. (Tokyo:4507).

EC approves Menarini’s rare blood disorder therapy
The European Commission approved Elzonris tagraxofusp from The Menarini Group as monotherapy to treat first-line blastic plasmacytoid dendritic cell neoplasm. The orphan drug, which targets CD123, is the first to be approved in Europe for BPDCN, according to the company. FDA approved the drug in 2018.

July PDUFA data for Incyte’s retifanlimab
FDA granted priority review to a BLA for retifanlimab from Incyte Corp. (NASDAQ:INCY) to treat locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy. The PDUFA date for the PD-1 inhibitor is July 25. 

Esbriet under FDA review for broader label
The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said FDA granted priority review to an sNDA for Esbriet pirfenidone to treat unclassifiable interstitial lung disease, with a decision is expected by May. 

Japan trial start for Moderna vaccine
Moderna Inc. (NASDAQ:MRNA) and  Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) began a Phase I/II trial of mRNA-1273 (TAK-919), Moderna’s COVID-19 vaccine, in Japan. The trial, which will enroll 200 volunteers aged 20 and up, is Moderna’s first in the country. Takeda plans to import 50 million doses of the vaccine candidate starting in the first half, pending authorization. 

TARGETS
CD123 – IL-3 receptor α