Posted from: Friday, December 01, 2017 - 12:51 PM - Present

Fasenra Approved for Severe Asthma

November 15, 2017 – The U.S. FDA has approved Fasenra™ (benralizumab), manufactured by AstraZeneca, to be used as an add-on maintenance treatment for patients with severe eosinophilic asthma who are 12 years of age or older. The drug works to reduce the frequency of severe asthma attacks by blocking interleukin-5 (IL-5) receptors. These receptors are found on white blood cells, and play a role in the increased respiratory sensitivity experienced by asthma patients. 

Severe asthma affects up to 10% of asthma patients in the United States, based on figures from the U.S. Centers for Disease Control and Prevention (CDC). An estimated 50% of these patients have the eosinophilic phenotype.  In clinical studies, Fasenra reduced the occurrence of asthma attacks by 50% per year compared to usual asthma medications combined with a placebo. In these studies, the majority of patients on Fasenra were able to reduce or discontinue their use of oral corticosteroids.

Recommended dosing for Fasenra is one 30mg subcutaneous injection, delivered by a healthcare professional, once per month for the first three doses. Afterward, Fasenra should be given once every two months. Two additional IL-5 inhibitors are currently available in the U.S.: Cinqair® (reslizumab), manufactured by Teva, and Nucala® (mepolizumab), manufactured by GlaxoSmithKline. Cinqair requires intravenous infusion, while Nucala can be delivered via subcutaneous injection. Both require monthly administration by a healthcare professional.

Fasenra has already been launched.


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 Friday, September 20, 2019 - 05:17 AM.