Posted from: Friday, July 07, 2017 - 02:25 PM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Wednesday, July 26, 2017 - 11:05 PM.