U.S. FDA concerned with Lundbeck drug death risk

U.S. regulators remain concerned about a possible risk of sudden death with H Lundbeck A/S’s proposed schizophrenia drug Serdolect, documents released on Friday said.

Food and Drug Administration reviewers, in a memo prepared for an advisory panel, said the drug appeared effective for treating schizophrenia but also noted data suggesting Serdolect patients had a higher chance of sudden cardiac death.

Lundbeck said the drug offered a distinct advantage, reducing suicidal behavior, which outweighed any risks.

The FDA will ask an advisory panel that meets Tuesday if there is enough evidence to back a claim of reduced suicidal behavior, and whether the drug is safe and effective for schizophrenia.

“There remains… a concern about a possible risk of sudden cardiac death with this drug,” Dr. Thomas Laughren, director of the FDA’s division of psychiatry products, wrote in a March 10 memo.

Lundbeck said Serdolect, which has been sold in Europe for years, reduced the risk of suicide attempts by up to 50 percent and potential side effects could be managed.

“With this positive benefit-risk profile, (Serdolect) offers an effective treatment modality,” the company said in a summary prepared for the FDA panel.

WASHINGTON (Reuters)