U.S. panel backs Lundbeck drug for some schizophrenics
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A drug from H Lundbeck A/S is safe enough to win approval for some patients with schizophrenia despite concerns it may raise the risk of sudden death, a U.S. advisory panel said on Tuesday.
The panel voted 8-2 to urge the Food and Drug Administration to make the drug, Serdolect, available for certain patients who need new options to battle the serious disease that causes hallucinations, delusions, and disorganized thought. Many patients with schizophrenia do not respond adequately to current therapies.
“I’m cognizant of the need for having available an array of different treatments for this devastating condition,” said panel chairman Wayne Goodman of the National Institute of Mental Health.
Three panel members abstained from the vote.
Lundbeck officials had argued that taking Serdolect offered a distinct benefit by reducing suicide attempts, a major risk for patients with schizophrenia. The panel, in a separate 12-1 vote, said the company’s evidence was not strong enough to make that claim.
The FDA will consider the panel recommendations as it decides whether to approve Serdolect, known generically as sertindole. A decision is expected by May 15.
The original application for U.S. approval was filed in 1995 but pulled three years later amid concerns it might cause heart problems. Sales in Europe were suspended in 1999 but resumed in 2006, after additional studies reassured regulators about Serdolect’s safety.
FDA reviewers told the panel they remained concerned about cases of sudden cardiac death in a Lundbeck study of about 10,000 patients who were given either Serdolect or another drug, risperidone. Thirteen patients given Serdolect suffered sudden death, compared with three who got the other medicine, FDA reviewer Phillip Kronstein said.
Panel members agreed the drug was effective to treat schizophrenia symptoms and a majority said it should be an option for some patients. Some said it should not be the first drug to try given the heart-related risks.
“I do believe this would be somewhere down the therapeutic choice chain,” said Robert Harrington, a cardiologist at Duke University Medical School.
Harrington said he was “concerned there is a real safety risk here that patients and their caregivers would have to be adequately informed about.”
Lundbeck told the panel the risk of heart problems was low and its research showed the chances of dying while taking the drug were similar to other schizophrenia medicines.
The company said it would work with the FDA to develop a plan to minimize risks and proposed adding a strong warning to withhold Serdolect from patients with known risks for heart problems.
“We believe this is an important drug for patients,” Lundbeck Senior Medical Officer Anders Gersel Pedersen said.
Danish drugmaker Lundbeck generates most of its revenue from Cipralex, a blockbuster antidepressant sold in the United States as Lexapro. The patents on Cipralex expire in major markets in 2012 to 2014 and the company has been struggling to replace it with new products.
By Lisa Richwine
SILVER SPRING, Maryland (Reuters)
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