April 2, 2018 / 11:07 AM / 6 months ago

BRIEF-Alkermes Receives Refusal To File Letter From FDA For ALKS 5461

April 2 (Reuters) - Alkermes Plc:

* ALKERMES RECEIVES REFUSAL TO FILE LETTER FROM FDA FOR ALKS 5461

* ALKERMES PLC SAYS "STRONGLY DISAGREES WITH FDA'S CONCLUSIONS AND PLANS TO APPEAL FDA'S DECISION"

* UPON ITS PRELIMINARY REVIEW, FDA HAS TAKEN POSITION THAT IT IS UNABLE TO COMPLETE A SUBSTANTIVE REVIEW OF REGULATORY PACKAGE

* ‍FDA REQUESTED CONDUCT OF BIOAVAILABILITY STUDY TO GENERATE ADDITIONAL BRIDGING DATA BETWEEN ALKS 5461 & REFERENCE LISTED DRUG, BUPRENORPHINE​

* INTENDS TO SEEK IMMEDIATE GUIDANCE, INCLUDING REQUESTING A TYPE A MEETING WITH FDA TO DETERMINE NEXT STEPS REQUIRED TO RESUBMIT NDA

* ISSUED FINANCIAL GUIDANCE FOR 2018 Source text for Eikon: Further company coverage:

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