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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