MHRA grants marketing authorization for oral, once-daily berotralstat (Orladeyo) for routine prevention of recurrent hereditary angioedema (HAE) attacks in patients 12 years and older
The company say this is the first and only oral therapy designed specifically to prevent attacks of HAE in adult and paediatric patients ≥12 years and older, by decreasing the activity of plasma kallikrein. Decision from NICE and SMC is anticipated end of 2021.
Source:
Biospace Inc.
SPS commentary:
In phase 3 APeX-2 trial, patients who completed 48 weeks of treatment (150 mg) saw reductions in attack rates, from a mean of 2.9 attacks per month at baseline to a mean of 1.0 attacks per month. In long-term open label APeX-S trial, patients completing 48 weeks of therapy (150 mg) had a mean attack rate of 0.8 attacks per month.