AstraZeneca and its partner Amgen Inc. announced that the US Food and Drug Administration granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma.
A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results and may demonstrate substantial over available medicines.
Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said: “Tezepelumab is exciting because it has the potential to treat a broad population of severe asthma patients, including those ineligible for currently-approved biologic therapies. The Breakthrough Therapy Designation will help us bring tezepelumab to patients as quickly as possible.”
This is the seventh Breakthrough Therapy Designation that AstraZeneca has received from the FDA since 2014, and the first for the company in respiratory medicine. Tezepelumab is currently in development in the Phase III Pathfinder clinical trial programme.
Asthma affects 334 million people worldwide, and up to 10% of asthma patients have severe asthma, which may be uncontrolled despite high doses of standard-of-care asthma controller medicines and can require the use of chronic oral corticosteroids (OCS).
Severe uncontrolled asthma is debilitating and potentially fatal.
AstraZeneca employs about 1,500 in northern Delaware.
