BioCentury
ARTICLE | Clinical News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

October 26, 2018 7:29 PM UTC

EMA’s CHMP on Oct. 19 recommended several approvals, including hereditary angioedema (HAE) mAb Takhzyro lanadelumab, dengue vaccine Dengvaxia and Herceptin trastuzumab biosimilar Ogivri.

CHMP backed Takhzyro from Shire plc (LSE:SHP; NASDAQ:SHPG) to prevent recurrent attacks of HAE. FDA approved the human mAb against plasma kallikrein (KLKB1) for the indication in August (see “FDA Approves Shire’s Takhzyro, First mAb to Prevent HAE”)...