(CercleFinance.com) – Ipsen announces that the United States Food and Drug Administration (FDA) has announced its decision to postpone the meeting of the Advisory Committee on Treatments for Endocrine and Metabolic Diseases concerning the investigational drug palovarotene, initially scheduled for October 31.
The delay is related to a new request for information from the FDA on clinical trial data on palovarotene, and does not concern the drug’s safety profile, Ipsen said.
The biopharmaceutical group indicates that it is currently working to address this request and is determined to offer innovative treatment options to the community of patients with progressive fibrodysplasia ossificans.
“We will work quickly with the FDA to achieve our goal as soon as possible,” adds Ipsen.
In this context, a new date for the meeting of the Advisory Committee should be confirmed soon.
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