Sunovion Pharmaceuticals has acknowledged that its NDA for its chronic obstructive pulmonary disease (COPD) treatment candidate SUN-101/eFlow® (glycopyrrolate) has been rejected by the FDA.
The company said it received a Complete Response Letter (CRL) from the FDA in response to its NDA for SUN-101/eFlow, which is indicated for long-term maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.
A terse statement by Sunovion issued May 26, just before the long Memorial Day holiday in the U.S., did not offer an explanation for why the FDA rejected the treatment.
“Sunovion will work with the FDA to determine an appropriate path forward. We are confident in SUN-101/eFlow and are committed to bringing this innovative therapy to COPD patients in the U.S. as quickly as possible,” the company stated.
Sunovion added that the CRL does not require the company to conduct any additional clinical studies for approval of SUN-101/eFlow.
SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator delivered via the proprietary investigational eFlow closed system nebulizer. SUN-101/eFlow is being developed as a nebulized treatment for patients with moderate-to-very-severe COPD.
Sunovion is an indirect, wholly owned subsidiary of Sumitomo Dainippon Pharma formed in 2010. Two years later, Sunovion inherited SUN-101, then named EP-101, when it acquired Elevation Pharmaceuticals for up to $430 million, of which $100 million was to be paid upfront. As part of that deal, Sunovion agreed to pay Elevation a $100 million commercial milestone payment tied to achieving regulatory approval for the COPD candidate.
The regulatory setback to Sunovion comes a week after developers of a rival LAMA treatment for COPD, Theravance Biopharma and Mylan, trumpeted positive data from 3-month, Phase III studies for their candidate revefenacin (TD-4208) at the American Thoracic Society (ATS) International Conference in Washington, D.C.
Theravance and Mylan said that revefenacin showed statistically significant and clinically meaningful improvements over placebo in the primary endpoint of trough forced expiratory volume in one second (FEV1) and in a key secondary endpoint of overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing in each study and for each of the revefenacin doses studied (88 μg once daily and 175 μg once daily).
Improvements in trough FEV1 versus placebo for the intent-to-treat populations across both studies were 118 mL and 145 mL for 88 μg and 175 μg, respectively. And improvements in OTE FEV1 versus placebo for the intent-to-treat population across both studies were 112 mL and 139 mL for 88 μg and 175 μg, respectively.