Sunovion slammed by FDA rejection of nebulized LAMA for COPD as rival lines up a competing NDA
The FDA has rejected a new COPD therapy from the US subsidiary of Sumitomo Dainippon, but there’s no word on what triggered the CRL. The setback offers Theravance Biopharma $TBPH and its partner Mylan a chance to catch up with a prominent rival therapy that’s winding through the final months of a late-stage program.
Late on Friday leading into the long Memorial Day weekend, Sunovion put out a short statement saying only that regulators had issued a complete response letter for SUN-101 (dubbed glycopyrrolate, which is used with an experimental nebulizer), its top late-stage therapy. The Marlborough, MA-based biotech added that regulators were not demanding any new trials and that execs would work with the FDA on moving forward.
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