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BRIEF-GSK gets EU greenlight for self-injectable version of lupus drug
September 15, 2017 / 11:08 AM / 8 days ago

BRIEF-GSK gets EU greenlight for self-injectable version of lupus drug

Sept 15 (Reuters) - GLAXOSMITHKLINE PLC:

* GSK RECEIVES CHMP POSITIVE OPINION FOR SELF-INJECTABLE FORMULATION OF BENLYSTA FOR SYSTEMIC LUPUS ERYTHEMATOSUS

* ‍POSITIVE OPINION WAS BASED ON RESULTS FROM BLISS-SC PHASE III PIVOTAL STUDY OF MORE THAN 800 PATIENTS WITH ACTIVE SLE​

* ‍A FINAL DECISION ON APPROVAL WILL BE MADE BY EUROPEAN COMMISSION, WHICH IS ANTICIPATED IN NEXT TWO TO THREE MONTHS

* ‍FURTHER REGULATORY SUBMISSIONS ARE UNDER REVIEW OR PLANNED IN OTHER COUNTRIES DURING COURSE OF 2017​​ Further company coverage:

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