Tezepelumab gets Breakthrough designation from US FDA

7 September 2018

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.

Tezepelumab is being developed by AstraZeneca (LSE: AZN) and its partner, US biotech firm Amgen (Nasdaq: AMGN), but the news hardly impacting shares, as the Anglo-Swedish pharma major edged up just 0.18% to 5,645 pence.

The Breakthrough Therapy designation, designed to expedite the development and regulatory review of medicines. is based on the tezepelumab Phase IIb PATHWAY data that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in a broad population of severe asthma patients irrespective of patient phenotype including Type 2 (T2) biomarker status.

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