Takeda and Lundbeck announced that the Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the supplemental New Drug Application (sNDA) regarding the addition of new clinical trial data to the Brintellix (vortioxetine) labeling for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD).
Brintellix was initially approved by the FDA in 2013 for the treatment of adults with MDD. In February 2016, the U.S. FDA Psychopharmacologic Drugs Advisory Committee (PDAC) voted in favor (8–2) that substantial evidence was presented to support a claim of efficacy for Brintellix in treating certain aspects of cognitive dysfunction in adults with MDD. Their vote was based on data from two 8-week, randomized, double-blind, placebo-controlled studies, FOCUS and CONNECT.
The Advisory Committee presents the FDA with independent expert advice and recommendations but the FDA is not bound by the committee’s guidance. Takeda and Lundbeck will review the contents of the CRL to determine the appropriate steps.
Brintellix is available as 5mg, 10mg, and 20mg strength tablets in 30-, 90-, and 500-count bottles.
For more information call (877) 825-3327 or visit Brintellix.com.