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.
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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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