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ARTICLE | Company News

CHMP backs Takhzyro, Dengue vaccine, biosimilar Herceptin

October 19, 2018 11:38 PM UTC

EMA’s CHMP recommended several approvals Friday, 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”)...