FDA Approves New Drug to Help Control Severe Asthma
THURSDAY, Dec. 23, 2021 (HealthDay News) -- For patients ages 12 years and older with severe asthma, the U.S. Food and Drug Administration has approved an injectable drug called Tezspire (tezepelumab-ekko), which would be administered every four weeks by a health care professional.
The medication is considered an add-on treatment meant to improve severe asthma in those whose condition is not controlled by their current medications. People who are prescribed Tezspire would continue to use other asthma treatments. Tezspire is unique because it is not limited to a specific type of severe asthma. It only targets thymic stromal lymphopoietin, the molecule involved in airway inflammation.
The FDA approved the drug after two clinical trials demonstrated that it was both safe and effective. Participants in the trials received either the drug or the placebo every four weeks for a year. Those who used the drug had fewer asthma attacks, including fewer attacks that led to emergency department visits and/or hospitalization.
Patients who start using Tezspire should not discontinue their inhaled or systemic corticosteroid asthma treatments abruptly. Any reductions should be gradual and under the direct supervision of a health care professional, the FDA said.
Those who have preexisting helminth infections should be treated before starting Tezspire. People who start taking Tezspire should not have live attenuated vaccines, including the measles-mumps-rubella, smallpox, and rotavirus vaccines. The drug should also not be used to treat short-term asthma symptoms or attacks.
Approval was granted to AstraZeneca and Amgen.
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