Eli Lilly sees favorable signs from FDA for approval of long-acting Zyprexa

INDIANAPOLIS Eli Lilly seems to believe that a long-acting form of its best selling drug, Zyprexa, which is used to treat schizophrenia, will likely become in the U.S. in the “near future,” based on favorable signs from the Food and Drug Administration, according to Reuters.

Lilly chief executive John Lechleiter said the company’s optimism is based on recent meetings between itself and the FDA, which in February had rejected the injectable form of Zyprexa. In issuing its “not approvable” letter, the FDA had said it needed more information to better understand the risk and underlying cause of excessive sedation seen in about 1 percent of patients given the injectable formulation in clinical trials.

Based on recent meetings with FDA officials, Lechleiter said Lilly thinks it can satisfy the agency’s concerns without conducting new clinical trials of the long-acting formulation and is hopeful it will soon become available to patients.

The basic form of Zyprexa had 2007 sales of $4.8 billion, but it will lose U.S. patent protection in 2011.