Brief: Minerva Neurosciences Receives Complete Response Letter From FDA

Minerva Neurosciences

27/02/2024 13:10

Feb 27 (Reuters) - Minerva Neurosciences Inc  NERV.O :
    * MINERVA NEUROSCIENCES RECEIVES COMPLETE RESPONSE LETTER
FROM FDA
FOR NEW DRUG APPLICATION FOR ROLUPERIDONE FOR THE TREATMENT OF
NEGATIVE SYMPTOMS IN PATIENTS WITH SCHIZOPHRENIA
    * MINERVA NEUROSCIENCES INC - WE BELIEVE THAT ROLUPERIDONE
IS A
SAFE AND EFFECTIVE THERAPY FOR NEGATIVE SYMPTOMS OF
SCHIZOPHRENIA
    * MINERVA NEUROSCIENCES INC - WILL REVIEW FDA'S FEEDBACK AND
CONSIDER OUR POTENTIAL PATHS FORWARD
    * MINERVA NEUROSCIENCES INC -  IN CRL, FDA CITED NDA
SUBMISSION
LACKS DATA ON CONCOMITANT ANTIPSYCHOTIC ADMINISTRATION
    * MINERVA-FDA CITED NDA SUBMISSION LACKS DATA TO ESTABLISH
CHANGE
IN NEGATIVE SYMPTOMS OF SCHIZOPHRENIA WITH ROLUPERIDONE
TREATMENT CLINICALLY MEANINGFUL
    * MINERVA-FDA CITED WHILE MIN-101C03 SHOWED SIGNIFICANCE ON
MAIN
EFFICACY GOAL, INSUFFICIENT ON ITS OWN TO ESTABLISH SUBSTANTIAL
EFFECTIVENESS EVIDENCE
    * MINERVA -FDA CITED SUBMITTED SAFETY DATABASE HAD
INADEQUATE
NUMBER OF SUBJECTS EXPOSED TO ROLUPERIDONE AT PROPOSED DOSE (64
MG) FOR AT LEAST 12 MONTHS
    * MINERVA -FDA STATED CO MUST SUBMIT AT LEAST 1 ADDITIONAL
POSITIVE, ADEQUATE, WELL-CONTROLLED STUDY TO SUPPORT SAFETY AND
EFFECTIVENESS OF ROLUPERIDONE
    * MINERVA NEUROSCIENCES - FDA ALSO PROVIDED COMMENTS ON,
AMONG
OTHER ITEMS, CLINICAL PHARMACOLOGY, PRODUCT QUALITY,
BIOPHARMACEUTICS, NONCLINICAL ISSUES
    * MINERVA NEUROSCIENCES - CO MUST PROVIDE ADDITIONAL DATA TO
SHOW
SAFETY AND EFFICACY OF ROLUPERIDONE CO-ADMINISTERED WITH
ANTIPSYCHOTIC MEDICATIONS

Source text for Eikon:  ID:nGNX2VTSFk 
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