New Biologic Therapy Available for Broad Population of Severe Asthma Patients Without Phenotype or Biomarker Limitations

THOUSAND OAKS, Calif., Jan. 13, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and AstraZeneca today announced TEZSPIRE™ (tezepelumab-ekko) is now available for shipment to wholesalers in the U.S. TEZSPIRE was approved by the U.S. Food and Drug Administration (FDA) on Dec. 17, 2021 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.1 

"Severe asthma has historically been a complex disease for patients to manage and for physicians to treat," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "About 60 percent of people have multiple drivers of disease and may not respond well to existing treatments. TEZSPIRE was approved for a broad population of people living with severe asthma, and we look forward to getting this important medicine into the hands of millions of patients who have had an unmet medical need."

TEZSPIRE is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.2 TEZSPIRE is the first and only biologic for severe asthma that does not have a phenotype—eosinophilic or allergic—or biomarker limitation within its approved label.4-11 TEZSPIRE consistently and significantly reduced asthma attacks across Phase 2 and 3 clinical trials which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).2,3 

The most common adverse reactions (incidence ≥3% and more common than placebo) of TEZSPIRE are pharyngitis, arthralgia, and back pain.1

Amgen and AstraZeneca are committed to providing appropriate patients who are prescribed TEZSPIRE with affordable access to the medicine. The Tezspire Together Program offers provider and patient product resources and support, including information related to coverage, reimbursement and distribution. For more information about the Tezspire Together Program, call 1-888-TZSPIRE (1-888-897-7473) or visit Tezspire.com.

Amgen and AstraZeneca also provide patient assistance for TEZSPIRE for qualifying individuals with no or limited drug coverage by providing free medicines through the Tezspire Patient Assistance Program. For additional information, patients and caregivers may contact Tezspire Together.

TEZSPIRE™ (tezepelumab-ekko) U.S. IndicationTEZSPIRE 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.

TEZSPIRE™ (tezepelumab-ekko) Important Safety Information  CONTRAINDICATIONSKnown hypersensitivity to tezepelumab-ekko or excipients.

WARNINGS AND PRECAUTIONSHypersensitivity ReactionsHypersensitivity 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 DiseaseTEZSPIRE should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus.

Abrupt Reduction of Corticosteroid DosageDo 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) InfectionIt 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.

ADVERSE REACTIONS 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.

You may report side effects related to AstraZeneca products by clicking here.

About the NAVIGATOR and the PATHFINDER Clinical Trial ProgramIn addition to the Phase 2b PATHWAY trial, the Phase 3 PATHFINDER program included two trials, NAVIGATOR and SOURCE. 2,12-14 The program includes additional mechanistic and long-term safety trials.15

NAVIGATOR is a Phase 3, randomized, double-blinded, placebo-controlled trial in adults (18–80 years old) and adolescents (12–17 years old) with severe, uncontrolled asthma, who were receiving standard of care (SoC). SoC was treatment with medium- or high-dose inhaled corticosteroids (ICS) plus at least one additional controller medication with or without daily oral corticosteroid treatment. The trial population included approximately equal proportions of patients with high (≥300 cells per microliter) and low (