Advantage Brintellix? Lundbeck advances bid for cognitive label claim

Lundbeck has racked up data backing Brintellix's ability to improves thinking, decision-making and attention better than its antidepressant competition. Now the company is one step closer to touting the drug's cognitive advantages.

The FDA accepted Lundbeck's application to add information about Brintellix's cognitive effects to its official label. The agency will review the data and decide about the label by March 28, Lundbeck said in a statement.

A label update could mean big things for the Danish drugmaker as it looks to jumpstart sales for the Brintellix and gain ground in a market packed with rivals. Lundbeck, along with partner Takeda, once set a peak forecast for the drug at $2 billion after snagging FDA approval in 2013. But Brintellix's full year 2014 sales rang in at $28.4 million, much lower than the $271 million predicted by EvaluatePharma. And its first-quarter 2015 sales only amounted to $14.8 million.

A crowded market doesn't help matters. Brintellix faces stiff competition from rival meds and generics of GlaxoSmithKline's ($GSK) Paxil, Pfizer's ($PFE) Zoloft, Eli Lilly's ($LLY) Prozac and Valeant's ($VRX) Wellbutrin.

Still, the company is working hard to set its med apart, running 30 studies including trials that looked at Brintellix's ability to treat cognitive problems--an oft-overlooked aspect of depression. The studies showed that the drug's cognitive effects weren't only a side benefit of easing symptoms, but were actually a direct result of Brintellix therapy, researchers said at the time.

Lundbeck also scored a competitive advantage in a study comparing Brintellix's cognitive benefits with Lilly's Cymbalta. In that trial, Brintellix performed better than Cymbalta in improving cognitive problems. The data was enough to impress EU regulators, who backed a new use for the drug to improve cognitive function in adults with depression.

But Lundbeck could face a tough road ahead as it looks to increase its share for Brintellix and win over payers. In June, England's cost-effectiveness gatekeeper rejected the drug, saying that there was "no convincing evidence to show that vortioxetine was any more or less effective than other antidepressants." And Lundbeck still hasn't shown how the drug fits into the bigger picture of depression treatments, NICE said at the time, laying down another obstacle for the company as it pushes for more widespread adoption of Brintellix.

- here's Lundbeck's statement

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