May 22, 2020 / 8:25 PM / 9 days ago

BRIEF-Zealand Pharma Announces FDA Acceptance Of New Drug Application For The Dasiglucagon Hypopal Rescue Pen

May 22 (Reuters) - Zealand Pharma A/S:

* REG-ZEALAND PHARMA ANNOUNCES FDA ACCEPTANCE OF NEW DRUG APPLICATION FOR THE DASIGLUCAGON HYPOPAL® RESCUE PEN FOR TREATMENT OF SEVERE HYPOGLYCEMIA

* PDUFA TARGET ACTION DATE SCHEDULED FOR MARCH 27, 2021

* FDA HAS COMMUNICATED THAT IT IS NOT CURRENTLY PLANNING ON AN ADVISORY COMMITTEE TO DISCUSS APPLICATION

* COMPANY REMAINS ON TRACK FOR POTENTIAL LAUNCH OF DASIGLUCAGON HYPOPAL RESCUE PEN IN EARLY 2021

* IN THREE PHASE 3 TRIALS IN ADULTS AND PEDIATRICS, PRIMARY AND ALL KEY SECONDARY ENDPOINTS WERE SUCCESSFULLY ACHIEVED

* ZEALAND-PRIMARY&ALL KEY SECONDARY ENDPOINTS ACHIEVED WITH MEDIAN TIME TO BLOOD GLUCOSE RECOVERY OF 10 MINUTE FOLLOWING INJECTION OF 0.6MG DASIGLUCAGON Source text for Eikon: Further company coverage:

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