ايف ڊي اي شديد اسٿما لاءِ نئين اضافي علاج جي منظوري ڏني

Tezspire was approved following a Priority Review by the FDA and based on results from the PATHFINDER clinical trial program. The application included results from the pivotal NAVIGATOR Phase 3 trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.

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.3 It is the first and only biologic to consistently and significantly reduce asthma exacerbations 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 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.

Results from the NAVIGATOR Phase 3 trial were published in The New England Journal of Medicine in May 2021.2 In clinical studies of Tezspire, the most common adverse reactions were nasopharyngitis, upper respiratory tract infection and headache.

Tezspire is under regulatory review in the EU, Japan and several other countries around the world.

Commitment to Patient Support

Amgen and AstraZeneca are committed to providing appropriate patients who are prescribed Tezspire with affordable access to the medicine. Patients, caregivers and physicians who need support or resources can contact the Tezspire Together program starting on Monday, Dec. 20 at 8:00 a.m. ET by calling 1-888-TZSPIRE (1-888-897-7473).

Tezspire™ (tezepelumab-ekko) U.S. Indication

Tezspire is a first-in-class medicine 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 

ڪانگريس

Known hypersensitivity to tezepelumab-ekko or excipients.

خبردار ۽ احتياط

انتهائي حساسيت جي رد عمل

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.

لائيو Attenuated ويڪسين

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.

وڌندڙ رد عمل

The most common adverse reactions (incidence ≥3%) are pharyngitis, arthralgia, and back pain.

مخصوص جڳهن ۾ استعمال ڪريو

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.