FDA Approvals, Highlights, and Summaries: Pulmonology 

February 17, 2022

Tezspire (tezepelumab)

Tezepelumab is a first-in-class human monoclonal antibody immunoglobulin G2-lambda that inhibits thymic stromal lymphopoietin (TSLP). It is indicated for add-on maintenance treatment of severe asthma in adults and pediatric patients aged 12 years and older.

Approval was based on the NAVIGATOR phase 3, multicenter, randomized, double-blind, placebo-controlled trial. Patients (age, 12-80 years) were randomly assigned to receive tezepelumab (210 mg) or placebo subcutaneously every 4 weeks for 52 weeks. Of 1061 patients who underwent randomization, 529 were assigned to receive tezepelumab and 532 to receive placebo. The annualized rate of asthma exacerbations was 0.93 with tezepelumab and 2.10 with placebo (P<0.001). Additionally, in patients with a blood eosinophil count less than 300 cells per microliter, the annualized rate was 1.02 with tezepelumab and 1.73 with placebo (P<0.001). At Week 52, improvements were greater with tezepelumab than with placebo with respect to the prebronchodilator FEV1 (0.23 vs. 0.09 liters; P<0.001). N Engl J Med. 2021 May 13;384(19):1800-1809

Other pulmonology approvals

Prograf (tacrolimus) - Received FDA approval for prophylaxis of organ rejection in lung transplant recipients in combination with other immunosuppressants.

Tyvaso (treprostinil inhaled) - New indication granted for treatment of adults with pulmonary hypertension associated with interstitial lung disease (World Health Organization Group 3) to improve exercise ability.

Actemra (tocilizumab) - New indication approved for adults to slow the rate of decline in pulmonary function in adults with systemic sclerosis–associated interstitial lung disease.


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