CSL Behring’s Haegarda (C1 Esterase Inhibitor) Receives the US FDA’s Approval for Pediatric Patients with Hereditary Angioedema

 CSL Behring’s Haegarda (C1 Esterase Inhibitor) Receives the US FDA’s Approval for Pediatric Patients with Hereditary Angioedema

CSL Behring’s Haegarda (C1 Esterase Inhibitor) Receives the US FDA’s Approval for Pediatric Patients with Hereditary Angioedema

Shots:  

  • The approval is based on P-lll COMPACT pivotal study and OLE study assessing Haegarda (C1 Esterase Inhibitor, SC) vs PBO in patients aged ≤17yrs. with symptomatic HAE.  
  • Results of COMPACT pivotal study: 95% reduction in the number of HAE attacks, 99% reduction in the use of rescue medication. COMPACT OLE results: all patients experienced a>50% reduction in the number of attacks/ mos. with a 97% reduction in the median number of attacks/ mos. (0.11). All had less than 1 attack/4wks. period and four had >1attack/yr. (one subject was attack free) while no one discontinues the treatment due to AEs
  • Haegarda is a self-administered, plasma-derived concentrate of C1-esterase inhibitor and the only SC therapy approved in the US for routine prophylaxis to prevent HAE attack in patients aged ≥6yrs.

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: CSL Behring

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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