AstraZeneca today announced that the US Food and Drug Administration
(FDA) has issued a complete response letter regarding the New Drug
Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol
fumarate), an inhaled triple-combination therapy and potential new
medicine for patients with chronic obstructive pulmonary disease (COPD).
The NDA submitted to the FDA by AstraZeneca included data from the
Phase III trial KRONOS. The Company will now work closely with the FDA
regarding next steps, including submitting for review recent results
from the second positive Phase III trial, ETHOS, which was not completed
at the time the NDA was submitted.
PT010 was approved in Japan (https://www.astrazeneca.com/media-centre/press-releases/2019/breztri-aerosphere-pt010-approved-in-japan-for-patients-with-chronic-obstructive-pulmonary-disease-19062019.html) in
June 2019 as Breztri Aerosphere, a triple-combination therapy to
relieve symptoms of COPD. PT010 is under regulatory review in China
where it has been granted priority review by the National Medical
Products Administration, and is also under regulatory review in the EU.
https://www.marketscreener.com/ASTRAZENECA-4000930/news/AstraZeneca-Update-on-US-regulatory-review-of-PT010-in-COPD-29317116/
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