Industry Briefs

FDA Rejects Cognitive Claim for Brintellix

The Food and Drug Administration (FDA) has declined to expand the approval for the antidepressant Brintellix (vortioxetine) to include cognitive dysfunction in adults with major depressive disorder (MDD). This rejection was somewhat unexpected after the FDA’s Psychopharmacologic Drugs Advisory Committee voted 8-2 to expand the indication to include cognitive dysfunction after Brintellix demonstrated a statistically significant improvement in cognitive performance over placebo and the antidepressant duloxetine.

In a statement, the manufacturers of Brintellix—Takeda Pharmaceutical Company Limited and H. Lundbeck A/S—expressed disappointment in the FDA’s response, but noted that they “were pleased that the FDA recognized the importance of cognitive dysfunction in MDD and view it as a legitimate target for drug development.”

Federal Judge Dismisses Birth Defect Claims Against Zoloft

A federal judge in Philadelphia has dismissed 311 lawsuits against Pfizer alleging its antidepressant Zoloft (sertraline) caused congenital heart defects in infants.

In making the decision earlier this month, U.S. District Judge Cynthia Rufe said that the plaintiffs had not produced enough evidence to show a plausible scientific link between the medication and birth defects.

Pfizer has faced numerous claims that they did not adequately warn patients about the potential risks of taking Zoloft during pregnancy. The company has maintained that it kept the FDA and the public abreast of all safety issues associated with the antidepressant.

Though most of the suits were dismissed, a handful of claims are still pending in the courts; Pfizer has prevailed in two previous trials involving birth-defect claims in state courts in Philadelphia and Missouri. ■