FDA Approves Tezepelumab (Tezspire) for Severe Asthma

[medscape.com DISCLOSURES December 20, 2021]

​

FDA has approved tezepelumab (Tezspire) as a first in class treatment for severe asthma in adults and pediatric patients aged 12 years and older. It is not recommended for the relief of acute bronchospasm or status asthmaticus. Tezepelumab is a human monoclonal antibody that acts as a thymic stromal lymphopoietin (TSLP) blocker. TSLP is an epithelial-cell–derived cytokine implicated in the pathogenesis of asthma. Tezepelumab is administered by subcutaneous injection at a recommended dosage of 210 mg given once every 4 weeks.

The approval was based on the results of various clinical trials primarily the NAVIGATOR phase 3 trial.   In the NAVIGATOR trial, a total of 1061 patients were randomly assigned to receive tezepelumab (529 patients) or placebo (532 patients).  With tezepelumab, the annualized rate of asthma exacerbations was 0.93; with placebo, the rate was 2.10 (P < .001).  The drug should not be used to treat acute asthma symptoms, acute exacerbations, acute bronchospasm, or status asthmaticus, and due to interaction with tezepelumab, live/ attenuated vaccines should be avoided.

​

++++++++++++++++++++

​

​

​

美国食品和药物管理局批准Tezepelumab（Tezspire）用于治疗严重哮喘

[medscape.com DISCLOSURES December 20, 2021]

​

FDA已批准Tezepelumab (Tezspire)作为治疗12岁及以上成人和儿童患者的严重哮喘, 它是第一类作用于胸腺基质淋巴细胞生成素（TSLP）阻断剂。它不被推荐用于缓解急性支气管痉挛或哮喘状态。Tezepelumab是一种人类单克隆抗体，作为胸腺基质淋巴细胞生成素（TSLP）阻断剂发挥作用。TSLP是一种上皮细胞衍生的细胞因子，与哮喘的发病机制有关。Tezepelumab通过皮下注射给药，建议剂量为210毫克，每4周一次。

FDA批准的依据主要是NAVIGATOR 3期试验。  在NAVIGATOR试验中，共有1061名患者被随机分配接受tezepelumab（529人）或安慰剂（532人）。 使用tezepelumab，哮喘恶化的年化率为0.93；使用安慰剂，该比率为2.10（P < .001）。该药不应被用于治疗急性哮喘症状、急性加重、急性支气管痉挛或哮喘状态，并且，由于与tezepelumab的相互作用，应避免使用活/减毒疫苗。