July 8, 2020 / 11:44 AM / a month ago

BRIEF-Biogen Completes Submission Of Biologics License Application To FDA For Aducanumab As A Treatment For Alzheimer’s Disease

July 8 (Reuters) - Biogen Inc:

* BIOGEN COMPLETES SUBMISSION OF BIOLOGICS LICENSE APPLICATION TO FDA FOR ADUCANUMAB AS A TREATMENT FOR ALZHEIMER’S DISEASE

* BIOGEN INC - AS PART OF COMPLETED SUBMISSION, BIOGEN HAS REQUESTED PRIORITY REVIEW.

* BIOGEN INC - COMPLETION OF BLA SUBMISSION FOLLOWED A PLANNED PRE-BLA MEETING WITH FDA.

* BIOGEN - BIOGEN HAS CONTINUED TO ENGAGE IN DIALOGUE WITH REGULATORY AUTHORITIES IN OTHER MARKETS, INCLUDING EUROPE AND JAPAN

* BIOGEN INC - IF ACCEPTED, BIOGEN EXPECTS FDA WILL ALSO INFORM IF BLA HAS BEEN GRANTED PRIORITY REVIEW DESIGNATION Source text for Eikon: Further company coverage:

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