Goodbye, Brintellix, and hello, Trintellix. Lundbeck and Takeda are changing the name on their antidepressant to end prescribing confusion with AZ's blood thinner Brilinta.
As the FDA warned in a recent safety alert, healthcare professionals were confusing Brintellix with AstraZeneca’s ($AZN) blood thinner Brilinta. So the companies and the FDA agreed on a new moniker for the med. The change will go into effect in June, the agency said.
“Due to continued reports of name confusion between the two medicines used for very different purposes, FDA worked with Brintellix manufacturer Takeda Pharmaceuticals to change the drug's brand name," the FDA said in a statement. “No other changes will be made to the label or packaging, and the medicine is exactly the same.”
Last year, the FDA put out a safety alert warning that name confusion between Brintellix and Brilinta triggered prescribing and dispensing errors. The agency recommended reducing the risk by including the drug’s generic name, brand name and indication for use when prescribing.
The new name could simplify matters, but it may take a while before people see bottles labeled Trintellix. “Because of the lag time associated with manufacturing bottles with the new brand name, healthcare professionals and patients may continue to see bottles labeled with the brand name Brintellix during the transition period,” the FDA said.
Meanwhile, Lundbeck is working to set the drug apart in other ways. The company is pushing the FDA to tweak the drug's label with data on its cognitive benefits in depressed patients. The updated label would help Brintellix achieve its blockbuster aspirations, the company figures.
The agency thwarted those hopes last month, however--at least for now. An FDA advisory panel backed the new claim, which would have made Brintellix “the only product on the market with a leaflet on cognitive effects,” brokerage firm Alm. Brand wrote in a recent note to clients. But the agency shot down the label change, although the two companies say they'll work with the FDA on a potential follow-up attempt.
In surprise decision, FDA blocks crucial cognitive claim for Takeda's Brintellix
FDA panel backs game-changing cognitive claim for Lundbeck antidepressant Brintellix
Advantage Brintellix? Lundbeck advances bid for cognitive label claim
Think fast: A new cognition study could add $350M to Lundbeck's Brintellix sales
FDA approves Lundbeck, Takeda antidepressant Brintellix