7th Sep 2018 08:05
LONDON (Alliance News) - AstraZeneca PLC on Friday said its asthma drug tezepelumab has been given a breakthrough therapy designation by the US Food & Drug Administration.
This designation has been given on the basis of phase IIb Pathway data, which showed that to tezepelumab reduced the annual exacerbation rate of severe asthma when compared to a placebo.
"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," said Astra Executive Vice President Sean Bohen.
A breakthrough therapy designation is intended to hasten the development and review of medicines which treat serious conditions and have encouraging clinical results. The Food & Drug Administration provides more intensive guidance on breakthrough drugs, which become eligible for priority review.
Since 2014, the pharmaceutical giant has now received seven breakthrough designations, and tezepelumab will be the first in its respiratory medicine divisions. At present, tezepelumab is in development in a phase III clinical trial programme.
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