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...