AstraZeneca and Amgen's TEZSPIRE® (tezepelumab-ekko) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. TEZSPIRE is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label. The approval by the US Food and Drug Administration (FDA) was based on results from the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trial.

The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer TEZSPIREboth in the clinic and at home throughout the PATH-HOME trial. The improvements in asthma control and the safety profile of TEZSPIRE observed in the PATH-HOME trial were consistent with previous clinical trials.TEZSPIRE self-administration and the TEZSPIRE pre-filled pen are also approved in the European Union (EU) and are under regulatory review in several other countries around the world. TEZSPIRE is currently approved for the treatment of severe asthma in the US, EU, Japan and other countries.

CONTRAINDICATIONS: Known hypersensitivity to tezepelumab-ekko or excipients. Warnings and Precautions: Hypersensitivity Reactions: Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported.

These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). In the event of a hypersensitivity reaction, 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. 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. Indication: 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. TEZSPIREwill be available as a fixed-dose 210mg subcutaneous injection via a pre-filled, single-use auto-injector (the TEZSPIRE pre-filled pen) or via a pre-filled, single-use syringe (the TEZSPIREpre-filled syringe). Both are administered every four weeks.

The TEZSPIREpre-filledpenenables patients and caregivers to self-administer the medicine at home or in clinic via a simple process. The device is fitted with a safety guard and viewing window and has audible clicks at the start and end of the injection to guide patients. PATH-HOME was a Phase III multi-center, open-label, parallel-group trial designed to assess patient, caregiver and healthcare provider-reported functionality and performance of a single-use, pre-filled syringe (PFS) or auto-injector (AI) with a fixed 210mg dose of TEZSPIREadministered subcutaneously every four weeksin a clinic and in an at-home setting in 216 patients aged 12 years and older with severe asthma.

PATH-BRIDGE was a single-center, randomized, open-label, parallel-group Phase I trial in healthy people to compare the pharmacokinetic (PK) exposure following a single 210mg dose of TEZSPIRE by using a vial-and-syringe (V-S), PFS or pre-filled AI device. TEZSPIRE PK exposure was comparable following subcutaneous administration via V-S, PFS or AI. In addition, injection site-pain was low in severity and injection-site reactions were uncommon in all device groups.