FDA panel backs game-changing cognitive claim for Lundbeck antidepressant Brintellix

Lundbeck is hoping that a new FDA label will turn its new antidepressant into a blockbuster in the making. An agency advisory panel backed Brintellix as a brainpower boost for people with depression.

If the FDA follows that advice, the drug would "be the only product on the market with a leaflet on cognitive effects," brokerage firm Alm. Brand wrote in a note to clients, as quoted by Reuters. The FDA is focusing on the drug's ability to improve thinking, attention and decision-making, "which means doctors also will," the firm said in its note, a potential boon for Lundbeck as it looks to reap more from the med.

The company already chalked up a victory in Europe after a study showed that Brintellix performed better than Eli Lilly's ($LLY) Cymbalta in improving cognitive problems in patients. Based on that data, EU regulators approved a new use for the drug to improve cognitive function in depressed adults.

Lundbeck CEO Kåre Schultz

An updated label could go a long way toward helping Lundbeck jumpstart sales for the drug. The company, along with partner Takeda, figured that Brintellix could bring in $2 billion in peak sales after winning approval in 2013. New CEO Kåre Schultz has similar blockbuster expectations for the med, hoping that it can pick up where the company's old blockbuster antidepressant, Cipralex, left off.

But so far, Brintellix has not exactly been living up to its blockbuster hype. The drug brought in $28.4 million in 2014 sales, much lower than the $271 million predicted by EvaluatePharma. Brintellix sales for the first 9 months of 2015 rang in at $62 million.

The drug also faces some stiff competition from well-entrenched rivals and generics of GlaxoSmithKline's ($GSK) Paxil, Pfizer's ($PFE) Zoloft, Eli Lilly's Prozac and Valeant's ($VRX) Wellbutrin.

In October, the U.K.'s cost-effectiveness watchdog backed Brintellix for depression after Lundbeck ponied up new data for the med. The move was an about-face for NICE, which had rejected the drug in June after finding that there was "no convincing evidence to show that (Brintellix) was any more or less effective than other antidepressants."

Even though the FDA is not bound to follow its committees' recommendations, it usually does. The agency is expected to hand down a final decision on Brintellix's cognitive claims label by March 28.

- read the Reuters story

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