Brief: Santhera Says EMA'S CHMP Grants Clock-Stop Extension In Authorization Of Puldysa

Santhera Pharmaceuticals Holding AG

29/05/2020 06:13

May 29 (Reuters) - SANTHERA PHARMACEUTICALS HOLDING AG
 SANN.S :
    * PROVIDES UPDATE ON THE ONGOING REGULATORY REVIEW OF
PULDYSA®
(IDEBENONE) BY THE CHMP IN DUCHENNE MUSCULAR DYSTROPHY (DMD)
    * EVALUATING POTENTIAL OF CONDUCTING AN INTERIM ANALYSIS TO
TEST
FOR SO-CALLED OVERWHELMING EFFICACY OF ITS SIDEROS STUDY
    * EMA'S CHMP HAS GRANTED A REQUESTED EXTENSION OF CLOCK-STOP
IN
REGULATORY PROCEDURE FOR ITS CONDITIONAL MARKETING AUTHORIZATION
(CMA) APPLICATION FOR PULDYSA® IN DUCHENNE MUSCULAR DYSTROPHY
    * THIS WILL RESULT IN A CHMP OPINION IN Q4 2020
    * POSITIVE EARLY COMPLETION OF SIDEROS STUDY WOULD ALLOW
ACCELERATION OF SUBSEQUENT REGULATORY FILINGS IN US AND EUROPE
BY APPROXIMATELY ONE YEAR
    * POSITIVE SIDEROS DATA COULD ALSO SHORTEN TIME TO A LABEL
EXTENSION TO INCLUDE GLUCOCORTICOID USING DMD PATIENTS BY AROUND
ONE YEAR

Source text for Eikon:  ID:nGNEC1QSf 
Further company coverage:  SANN.S 

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