U.S. declines to clear Schering schizophrenia drug

U.S. health regulators have declined to approve Schering-Plough Corp’s experimental drug for schizophrenia and bipolar disorder, requesting more data, the drugmaker said on Wednesday.

But the U.S. Food and Drug Administration’s complete response letter did not request additional clinical trials for the drug, Saphris, and included proposed product labeling for the medicine. Schering-Plough expects to provide the requested information to the agency in the first quarter.

Saphris, also called asenapine, was touted by Schering-Plough as one of five “stars” of its research pipeline at its investor meeting in November. It has forecast that Saphris sales could exceed $1 billion a year.

“We are pleased with the progress on the Saphris filing and look forward to working with the agency to address its request, finalize the product labeling and gain approval,” Thomas Koestler, president of the Schering-Plough Research Institute, said in a statement.

Schering-Plough gained asenapine through its 2007 acquisition of Organon BioSciences.

NEW YORK (Reuters)