BioCryst's Orladeyo (berotralstat) Receives NICE Recommendation as First Oral Therapy to Prevent HAE Attacks in the UK
Shots:
- The NICE recommendation is based on P-III APeX-2 trial evaluating Orladeyo vs PBO in adult & pediatric patients aged ≥12yrs. with HAE attacks
- The trial met its 1EPs i.e.- reduction in HAE attacks @24wks. & sustained through 96wks. with an 80% reduction in patients with mean HAE attack rate/mos. @ 25-96wks. The therapy was generally well-tolerated during the treatment period & fewer drug-related AEs were observed
- The recommendation also expands access to modern prophylaxis with the therapy compared to the attack frequency for injectable options. The SMC decision to use Orladeyo for HAE patients in Scotland under NHS is expected in H1’22
| Ref: Globe Newswire | Image: Biocryst
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