Shire HAE treatment from Dyax deal clears Phase III hurdle

Shire plc (LSE:SHP; NASDAQ:SHPG) will submit a BLA to FDA by early next year for subcutaneous lanadelumab (SHP643) to prevent hereditary angioedema (HAE) attacks after the compound met the primary endpoint in the Phase III HELP trial.

The double-blind, international, 26-week trial enrolled 125 patients ages 12 and over with Type I or II HAE and evaluated subcutaneous 300 mg lanadelumab every 2 or 4 weeks and 150 mg lanadelumab every 4 weeks. ...