Haegarda Approved for Hereditary Angioedema
June 22, 2017 – The U.S. FDA has approved Haegarda® (C1 esterase inhibitor subcutaneous [human]), manufactured by CSL Behring, for routine prophylaxis to prevent hereditary angioedema (HAE) attacks in adolescent and adult patients. HAE is an orphan disease that affects between 6,000 and 10,000 Americans. The genetic disorder is caused by a deficiency of C1 inhibitor. Patients with the disease experience recurrent, unpredictable inflammatory attacks affecting the larynx, abdomen, face, extremities and urogenital tract. These episodes can be life-threatening. Haegarda is not approved to treat acute HAE attacks.
The recommended dose for Haegarda is 60 international units (IU) per kilogram (kg) of body weight, injected subcutaneously twice weekly every 3 or 4 days. Haegarda can be administered at home by properly trained patients or caregivers to help prevent attacks.
CSL Behring plans to launch Haegarda during the third quarter of 2017. It is expected to be available through a limited network of specialty pharmacies. Pricing information is not yet available.
Shire has filed a lawsuit against CSL Behring in an attempt to block Haegarda’s launch, claiming the drug violates a recently issued patent. Shire’s C1 esterase inhibitor, Cinryze®, is also approved for routine prophylaxis against HAE attacks. Cinryze is administered as an intravenous infusion every 3 or 4 days. Litigation is ongoing.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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