Lundbeck shares slip as FDA seeks Serdolect data

Shares of H. Lundbeck took a hit overnight as investors digested the sour news that the FDA will need to see more data on its schizophrenia drug Serdolect before it extends an approval. That's a surprising setback. Lundbeck had been looking for an approval following an advisory panel vote largely in favor of the drug. 

Serdolect is already on the market in Europe and some analysts quickly concluded that the FDA roadblock could prove a deal killer for the U.S. market and may persuade Lundbeck to drop its plans if it appears that satisfying the FDA will cost too much. 

"It's already approved in Europe so if new U.S. testing becomes too expensive, they'll have to evaluate the benefits of drug approval for the U.S. market," Jyske Bank's Lars Terp Paulsen told Dow Jones. That kind of sentiment took a 1.9 percent bite out of the company's share price, which has slid 15 percent over the past year.

The agency's complete response letter includes a demand for more data on the drug's benefits to patients. And the Copenhagen-based drug company shows no immediate sign of backing off its quest for an FDA approval. "In the coming months Lundbeck is committed to addressing the FDA's Complete Response Letter (CRL) and will work with the agency to expedite completion of its review", the company said.

- check out the report from Dow Jones

ALSO: J&J and Schering-Plough, meanwhile, say that the EMEA is recommending approval of Simponi, a once-monthly treatment for arthritis. The drug is a follow-up to Remicade and was approved in the U.S. in April. Story

PLUS: Laboratoires Pierre Fabre announced that the Committee for Medicinal Products for Human Use is recommending approval of Javlor as monotherapy in the metastatic treatment of bladder cancer. Release

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