Lundbeck Slumps After FDA Rejects Brintellix Label Expansion

  • Shares down as much as 11 percent, most since December 2012
  • Jefferies analysts excluded potential expansion from estimates

H. Lundbeck A/S shares fell the most in more than three years after the U.S. Food and Drug Administration wouldn’t approve an expanded use of its antidepressant Brintellix.

The stock dropped as much as 11 percent, the steepest intraday decline since Dec. 19, 2012, when the Danish drugmaker slashed its sales and profit forecasts for the following two years. Lundbeck was down 9.9 percent to 223.50 kroner at 10:29 a.m. in Copenhagen trading.

U.S. regulators issued a complete response letter to Lundbeck and Japanese partner Takeda Pharmaceutical Co. declining to expand Brintellix’s approval to treat certain aspects of cognitive dysfunction in adults with major depressive disorder. The drug is already approved in the U.S. for major depressive disorder.

“Takeda and Lundbeck are disappointed with the response,” the companies said in a statement late Monday. “However, the companies were pleased that FDA recognized the importance of cognitive dysfunction in MDD and view it as a legitimate target for drug development.”

The companies said they will discuss next steps with the agency.

The setback followed an FDA advisory committee vote in favor of expanding the drug’s label. Analysts at Jefferies Group LLC said they were concerned regulators would “shy away from setting a precedent for a cognition claim,” and didn’t include potential sales for cognition in their estimates. The FDA may require new clinical trials before granting approval, Jefferies analyst Peter Welford wrote in a note to clients.

Brintellix may bring in as much as 3.79 billion kroner ($570 million) in 2020, according to the average of six analyst estimates compiled by Bloomberg.

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