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FDA approves first and only biologic drug, tezepelumab-ekko, to control exacerbation in severe asthma patients

The US Food and Drug Administration has approved the first and only biologic drug –   Astrazeneca and Amgen’s tezepelumab-ekko (Tezspire)– for severe asthmatic patients. The drug, which is indicated for patients of 12 years and above, claims to significantly reduce asthma exacerbations in a broad population of patients. Tezepelumab-ekkot, which targets epithelial cytokine thymic stromal lymphopoietin (TSLP) to control asthma/COPD exacerbation, has been approved with no phenotype or biomarker limitations.  The companies said that the approval came after their PATHFINDER clinical trial programme and NAVIGATOR Phase III trial, where the drug demonstrated its efficacy against placebo. The researchers expressed hopes that the drug will potentially transform COPD healthcare for a much broader population.

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