AstraZeneca receives FDA complete response letter for PT010
Posted: 2 October 2019 | Victoria Rees (European Pharmaceutical Review) | No comments yet
The FDA has given a complete response letter to AstraZeneca for its PT010 treatment, regarding its New Drug Application.
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate).
PT010 is a long-acting β2-agonist, delivered in a pressurised metred-dose inhaler”
PT010, produced by AstraZeneca, is an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD).
The pharmaceutical company has announced that they will be working closely with the FDA on their next steps. They have said they will hand over recent results from a second Phase III trial, not completed at the time the NDA was submitted.
PT010 is a long-acting β2-agonist, delivered in a pressurised metred-dose inhaler to treat the condition. COPD is a progressive disease which is estimated to affect 384 million people worldwide.
PT010 was approved in Japan and is under regulatory review in the EU and China, where it has been granted priority review.
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Clinical Development, Clinical Trials, QA/QC, Research & Development (R&D)
