The US FDA has granted approval to the first-in-class biologic drug “tezepelumab-ekko” for the treatment of severe asthma. It is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ) with no phenotype (e.g., eosinophilic or allergic) or biomarker limitations. TSLP is “an epithelial cytokine involved in inflammation and overactive immune response to several asthma triggers”. By blocking TSLP, tezepelumab-ekko inhibits release of proinflammatory cytokines and prevents exacerbations resulting in better asthma control. It is also the first treatment for severe asthma that is not limited to a specific type of severe asthma. 

The approval for tezepelumab-ekko was based on the findings of the NAVIGATOR and SOURCE trials, which demonstrated a decrease in annual rates of asthma, fewer hospitalizations or ER visits compared to placebo.

Formulations: Tezepelumab-ekko is available as a single-dose (210 mg/1.91 mL) pre-filled syringe or vial.

Indication: Tezepelumab-ekko is indicated for use in adults and children aged ≥12 years with severe asthma as an add-on maintenance treatment.

Dose & Administration: 210 mg once every 4 weeks through subcutaneous route

Side effects: Pharyngitis, arthralgia, back pain

Contraindications: Known hypersensitivity to tezepelumab-ekko or its excipients

Warning & Precautions: The FDA has cautioned that tezepelumab-ekko is not meant for use in patients with acute bronchospasm or status asthmaticus. Systemic or inhaled steroids should not be stopped abruptly after initiating treatment with tezepelumab-ekko. Instead, their dose should be reduced gradually under supervision, if required. Patients with pre-existing helminth infections should be treated for the helminth infection before starting therapy. Live attenuated vaccines should be avoided.

Source: US FDA, December 20, 2021. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-maintenance-treatment-severe-asthma