Shots:

• The approval is based on a pivotal P-III APeX-2 trial assessing Orladeyo (150 mg- qd) in adults and pediatric patients aged ≥12yrs. with HAE
• The study demonstrated reduction attacks @24wks. while the reduction was sustained through 48wks. with mean HAE attack rates of 2.9 attacks/mos. In the long-term open-label APeX-S trial- patients completing 48wks. of therapy had a mean attack rate of 0.8 attacks/mos.
• Orladeyo (PO) is designed specifically to prevent attacks of HAE in adults and pediatric patients aged ≥12yrs.

 ­ Ref: GlobeNewswire | Image: Biocryst