Tezspire™ (tezepelumab-ekko), a first-in-class medicine for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma, was approved by the U.S. Food and Drug Administration (FDA) today (December 17, 2021).1 The journey to bring this medicine to patients has been a deeply personal one for the team at Amgen. Formerly known as AMG 157, Amgen is excited to introduce Tezspire™.
Globally, there are approximately 2.5 million people living with severe asthma who are uncontrolled or biologic eligible, with approximately 1 million in the U.S.2-7 Severe asthma is debilitating, with individuals experiencing frequent symptoms and exacerbations, significant limitations on lung function and a reduced quality of life.4,5 The complexity and heterogeneity of asthma has made it a historically challenging disease to treat.
By targeting and blocking a key epithelial cytokine called thymic stromal lymphopoietin (TSLP) that sits at the top of the inflammatory cascade and acts as an alarmin for the immune system, Tezspire™ is able to reduce the release of downstream mediators of inflammation.1,8 The most common adverse reactions of Tezspire™ are pharyngitis, arthralgia and back pain.1
"I'm immensely proud of what we've done here. It's an incredible accomplishment every time a new drug based on science makes it into the hands of patients. That doesn't come easily. It takes more than a village—it takes an army, that army has worked for many years to come to this moment. That's what I'm really proud of," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "To me, this just goes to the heart of what Amgen does, it's why we're here, it's why I come to work every day."
Watch the Tezspire video above to hear about the medicine's journey from the scientists and researchers who brought this treatment from discovery to development as well as from a woman named Erin, who lives with severe asthma.
TEZSPIRE is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus.
IMPORTANT SAFETY INFORMATION
Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions (e.g., rash and allergic conjunctivitis) can occur following administration of TEZSPIRE. These reactions can occur within hours of administration, but in some instances have a delayed onset (i.e., days). In the event of a hypersensitivity reaction, initiate appropriate treatment as clinically indicated and then consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.
Acute Asthma Symptoms or Deteriorating Disease
TEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.
Abrupt Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with TEZSPIRE. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if TEZSPIRE will influence a patient's response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with TEZSPIRE. If patients become infected while receiving TEZSPIRE and do not respond to anti-helminth treatment, discontinue TEZSPIRE until infection resolves.
Live Attenuated Vaccines
The concomitant use of TEZSPIRE and live attenuated vaccines has not been evaluated. The use of live attenuated vaccines should be avoided in patients receiving TEZSPIRE.
The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.
USE IN SPECIFIC POPULATIONS
There are no available data on TEZSPIRE use in pregnant women to evaluate for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as Tezepelumab-ekko is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
Please see the Tezspire full Prescribing Information.
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- Tezspire (tezepelumab) US prescribing information; 2021.
- Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/asthma/most_recent_national_asthma_data.htm. Accessed November 2021.
- Kupczyk M, Wenzel S. J Intern Med 2012;272:121–32.
- Wenzel S. Am J Respir Crit Care Med. 2005;172;149–60.
- Chung KF, et al. Eur Respir J. 2014; 43: 343–73.
- Chastek, et al. J Manag Care Spec Pharm 2016;22:848-861.
- Chen, et al. Curr Med Res Opin 2018;34(12):2075-2088.
- Corren J, et al. N Engl J Med. 2017; 377: 936-946.