The US Food and Drug Administration refused to immediately approve a long-acting formulation of schizophrenia drug Zyprexa requesting its maker details regarding its risks.

 

Eli Lilly & Co.’s said Wednesday that it received a so-called complete response letter from the FDA. Receiving such a letter usually means that the FDA isn’t yet ready to approve a drug candidate. 

 

Currently, Zyprexa is approved as a once-daily tablet to treat schizophrenia and bipolar disorder. The long-acting formulation would be injected once every four weeks. The new version was approved in Europe in December under the name Zypadhera. Analysts have predicted annual sales for the long-acting formulation of around $125 million by 2011, when the basic form comes off-patent. The company aims to sell it under the name Zyprexa Adhera on the US market if approved.

 

“We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation of olanzapine will offer an important option for treating this devastating and chronic illness,” said Dr Todd Durell, associate medical director of US neuroscience at Eli Lilly.

 

Lilly Chief Executive John Lechleiter said Wednesday that the letter from the FDA indicated the company doesn’t need to generate new clinical data to support, but instead needs to give the agency more information about a so-called risk-management plan. Such plans make sure that a drug’s benefits outweigh its risks. The plan will be submitted in the near future, Lechleiter said.