March 29, 2016 / 5:15 AM / 3 years ago

BRIEF-Lundbeck and Takeda receive complete response letter by FDA for Brintellix (vortioxetine) sNDA

March 29 (Reuters) - Lundbeck :

* Says Lundbeck and Takeda receive complete response letter (CRL) by the U.S. Food and Drug Administration (FDA) for Brintellix (vortioxetine) supplemental new drug application (sNDA)

* FDA issued a CRL for sNDA to include new data in the clinical trials section of the U.S. label of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD)

* Complete response letter does not apply to use of Brintellix in MDD

* Says Takeda and Lundbeck are disappointed with the response given that the U.S. FDA Psychopharmacologic Drugs Advisory Committee (PDAC) voted 8 to 2 that Takeda and Lundbeck presented substantial evidence to support a claim of effectiveness for Brintellix in treating certain aspects of cognitive dysfunction in adults with MDD

* Parties look forward to reviewing the contents of the letter with the FDA to determine the appropriate path forward Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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