The late-stage drug is intended to serve as a long-term treatment for airflow obstruction in COPD patients. Sunovion did not share the FDA’s reason for rejecting the drug, but said the agency is not requiring the company to conduct additional clinical trials before reapplying for the drug’s approval.
“Sunovion will work with the FDA to determine an appropriate path forward,” the company said in a news release. “We are confident in [the drug] and are committed to bringing this innovative therapy to COPD patients in the U.S. as quickly as possible.”
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