February 27, 2018 / 3:20 PM / 3 months ago

BRIEF-Novo Nordisk Submits Haemophilia Drug For Approval in the U.S and the EU

Feb 27 (Reuters) - Novo Nordisk:

* FILES FOR REGULATORY APPROVAL OF LONG-ACTING FACTOR VIII (N8-GP) IN THE U.S. AND THE EU FOR TREATMENT OF HAEMOPHILIA A

* SAYS IN ‍TRIAL, ADULTS TREATED PROPHYLACTICALLY WITH N8-GP EVERY FOURTH DAY EXPERIENCED A MEDIAN ANNUALISED BLEEDING RATE OF 1.3 EPISODES COMPARED TO 30.9 EPISODES FOR PEOPLE TREATED ON-DEMAND

* PAEDIATRIC PARTICIPANTS EXPERIENCED A MEDIAN ANNUALISED BLEEDING RATE OF 1.95 EPISODES WHEN ADMINISTERED TWICE WEEKLY

* HAEMOSTATIC RESPONSE WAS REPORTED AS ‘EXCELLENT’ OR ‘GOOD’ IN 43 OUT OF THE 45 PERFORMED SURGERIES​ IN SURGERY TRIAL

* “BASED ON THE RESULTS FROM THE GLOBAL PATHFINDER CLINICAL TRIAL PROGRAMME, WE BELIEVE N8-GP CAN REDUCE THE BURDEN OF TREATMENT BY DECREASING THE NUMBER OF INTRAVENOUS INFUSIONS WHILE ACHIEVING THE BENEFITS IN TERMS OF EFFICACY AND SAFETY FOR PEOPLE WITH HAEMOPHILIA A,” CHIEF SCIENCE OFFICER MADS KROGSGAARD THOMSEN SAID. Source text for Eikon: Further company coverage:

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