Brief: Cosmo Announces Acceptance Of NDA Submission Of Cortiment MMX

Cosmo NV

28/06/2022 06:07

June 28 (Reuters) - COSMO PHARMACEUTICALS NV  COPN.S :
    * COSMO ANNOUNCES ACCEPTANCE OF NDA SUBMISSION OF CORTIMENT®
MMX®
IN JAPAN
    * REVIEW IS EXPECTED TO LAST APPROXIMATELY A YEAR
    * APPROVED DOSING REGIMEN FOR ADULT PATIENTS IS ONE 9 MG
TABLET
TAKEN ONCE DAILY FOR UP TO 8 WEEKS
    * ANNOUNCED THAT FERRING, OUR PARTNER FOR CORTIMENT® MMX®
(BUDESONIDE), SUBMITTED NDA FOR JAPAN ON JUNE 23, 2022, AND
APPLICATION HAS BEEN ACCEPTED BY PMDA (PHARMACEUTICALS AND
MEDICAL DEVICES AGENCY)
    * IN PHASE III STUDIES, 2.4 TO 3.9 TIMES MORE PATIENTS
ACHIEVED
CLINICAL REMISSION AND MUCOSAL HEALING WITH CORTIMENT® COMPARED
TO PLACEBO, AND NO CLINICALLY SIGNIFICANT GLUCOCORTICOSTEROID
SIDE EFFECTS WERE SEEN VERSUS PLACEBO AFTER EIGHT WEEKS OF
TREATMENT

Source text for Eikon:  ID:nEQ4tsM24a 
Further company coverage:  COPN.S 

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