Shots:
- The MHLW has approved Orladeyo (berotralstat) for prophylactic therapy in pediatric pts (2 to <12 yrs.) with hereditary angioedema (HAE)
- Approval was based on interim APeX-P trial results in pediatric pts with HAE, which showed early & sustained reductions in monthly attack rates; published in the Annals of Allergy, Asthma & Immunology
- BioCryst plans to launch Orladeyo for children in Japan after completing the NHI reimbursement pricing process, with OrphanPacific serving as its Japanese partner and marketing authorization holder
Ref: Globenewswire | Image: BioCryst Pharmaceuticals | Press Release
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