BioCentury
ARTICLE | Regulation

Nov. 23 Quick Takes: Priority review for Takeda’s dengue vaccine

Plus: Skyrizi snags third approval in Europe and a hemophilia update from BioMarin

November 23, 2022 11:47 PM UTC

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) said FDA granted priority to its BLA for dengue fever vaccine TAK-003 for use in individuals aged 4-60 years. The vaccine prevented 80.2% of symptomatic cases of dengue in the Phase III TIDES study. Most dengue infections in the U.S. occurred as a result of travel to areas where the disease is endemic; U.S. territories where dengue occurs include Puerto Rico, the U.S. Virgin Islands and American Samoa. Last month, EMA’s CHMP recommended the vaccine’s approval; it is already approved in Indonesia.

AbbVie Inc. (NYSE:ABBV) scored a third European indication for Skyrizi risankizumab on Wednesday, becoming the first IL-23 inhibitor to be approved by the European Commission to treat Crohn’s disease. Skyrizi is now approved to treat plaque psoriasis, psoriatic arthritis and Crohn’s disease in both the U.S. and EU. AbbVie is relying on Skyrizi and another autoimmune drug, Rinvoq upadacitinib, to help offset lost sales of Humira adalimumab after the blockbuster loses patent exclusivity next year...