GSK Says EMA Accepts Marketing Authorisation Application For Momelotinib

Published on December 02, 2022 07:27 AM GMT

GSK Says EMA Accepts Marketing Authorisation Application For Momelotinib — Image source: ©2022 Kalkine Media®

Dec 2 (Reuters) - GSK PLC :

* EMA FILE ACCEPTED FOR MOMELOTINIB

* EUROPEAN MEDICINES AGENCY ACCEPTS MARKETING AUTHORISATION APPLICATION FOR MOMELOTINIB FOR TREATMENT OF MYELOFIBROSIS

* APPLICATION HAS DATA FROM KEY PHASE III TRIALS, INCLUDING PIVOTAL MOMENTUM TRIAL, WHICH MET ALL PRIMARY AND KEY SECONDARY EFFICACY ENDPOINTS

* A NEW DRUG APPLICATION FOR MOMELOTINIB IS CURRENTLY UNDER REGULATORY REVIEW WITH US FOOD AND DRUG ADMINISTRATION Source text for Eikon:

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