Hereditary angioedema (HAE) is a disease characterized by recurrent and debilitating attacks of angioedema, or severe swelling of the limbs, airway, face, or intestinal tract. HAE affects about one in 10,000 to 50,000 individuals worldwide and can have a significant impact on quality of life. There are currently six FDA-approved therapies available for individuals with HAE; however, there is still an unmet need for this condition as new medications with sustained efficacy and less treatment burden are being sought out.
Lanadelumab is a fully human monoclonal antibody developed by Shire Plc (previously Dyax Corp, acquired by Shire in 2016). Lanadelumab received Priority Review from the FDA in February of 2018 and is under review for Prophylaxis of Hereditary Angioedema (HAE) Attacks and has a PDUFA action date set for August 26, 2018.
For our complete review of Lanadelumab:
Executive Summary of Evaluation:
Lanadelumab (Shire Plc)
|Orphan Drug Designation||
|FDA Fast Track Designation||
|Breakthrough Therapy Designation||
|Priority Review Designation||
|Indications||Hereditary Angioedema (HAE)||
Submitted for Approval (BLA)
|Efficacy||Hereditary Angioedema (HAE)||
Efficacy reported in Phase III Trials
Clinical Trial data obtained at https://clinicaltrials.gov/ct2/home Accessed: June 28, 2018.
“FDA Approved Treatments”. US Hereditary Angioedema Association (HAEA). https://www.haea.org/ApprovedTreatments.php. Accessed: June 29, 2018.
“Hereditary angioedema”. NIH U.S. National Library of Medicine: Genetics Home Reference. https://ghr.nlm.nih.gov/condition/hereditary-angioedema#resources. Accessed: June 28, 2018.
Global Data, Pharma Intelligence Center https://pharma.globaldata.com Accessed: May 30, 2018.
“Shire Reports Positive Topline Phase 3 Results for Lanadelumab (SHP643) in Patients With Hereditary Angioedema (HAE)”. Shire. http://investors.shire.com/~/media/Files/S/Shire-IR/presentations-webcast/year-2017/shire-investor-presentation-2017-05-18.pdf. Accessed: June 28, 2018.
“What is HAE?” HAEi.org. http://haei.org/hae/what-is-hae/. Accessed: June 28, 2018.
Additional 2018 Pipeline Reviews are available for the following drugs.
Coauthored by: Kristen Ciampi, PharmD
Kristen recently graduated with a PharmD degree from the University of Rhode Island in May of 2018, and is a Pharmacy Analytics Intern at RJ Health Systems.