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シャイア【SHPG】の掲示板
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Shire is building a portfolio of HAE drugs that meet different patient needs. The company already markets Firazyr icatibant, a self-administered therapy to treat acute attacks in patients aged 18 and older; Cinryze complement 1 (C1) esterase inhibitor, a prophylactic for patients with more severe disease; and Kalbitor ecallantide, a physician-infused therapy to treat patients 12 and up (see BioCentury, May 12).
On Thursday, Shire gained 83p to 4,814.5p in London and rose $7.83 to $190 on NASDAQ.
kaz*ヒト投与可能で一斉摘発ｗ
>>2
The company said 42.9% of lanadelumab-treated patients had injection site pain, the most common adverse event, vs. 29.3% for placebo. Lanadelumab is a mAb against plasma kallikrein.
Lanadelumab has Orphan Drug designation in the U.S. and EU and breakthrough therapy designation in the U.S. The company expects its BLA to receive Priority Review, and hopes to launch the product in 2H18. Shire is targeting 1H18 for an MAA submission.
The company gained lanadelumab in 2016 through its acquisition of Dyax Corp., whose shareholders are eligible for a contingent value right (CVR) worth $646 million if FDA approves the candidate by YE19 (see BioCentury Extra, Nov. 2, 2015).