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アメリカ東部時間18日午前7:54(日本時間19日午後8:54)CNBC
日本の規制当局は武田製薬による620億ドルでのシャイア買収を承認した。
この買収は既にアメリカ、ブラジル並び中国で承認されており、今後はEUでの承認待ちとなる。

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.

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).

Shire HAE treatment from Dyax deal clears Phase III hurdle

Shire plc (LSE:SHP; NASDAQ:SHPG) said it will submit a BLA to FDA by early next year for subcutaneous lanadelumab (SHP643) to prevent hereditary angioedema attacks. The company will base its submission on data from the Phase III HELP trial, in which three lanadelumab dose schedules each met the primary and all secondary endpoints (p<0.001 vs. placebo for all).

The 26-week trial evaluated 300 mg lanadelumab every two or four weeks or 150 mg lanadelumab every four weeks in 125 patients ages 12 and over with Type I or II HAE. The regimens reduced monthly HAE attack rate, the primary endpoint, by 87%, 73% and 76%, respectively. Shire said the effect was consistent irrespective of baseline attack rate and that each of the three regimens significantly increased the proportion of attack-free patients compared to placebo.

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