Regulators at the FDA presented Schering-Plough with a new obstacle for Saphris, its experimental therapy for schizophrenia and bipolar disorder, declining to give it an approval. But the agency did not request a new clinical trial, which would have significantly delayed its approval.
Saphris (asenapine) has been touted by Schering-Plough as one of the jewels in the company pipeline, with potential sales reaching past $1 billion. Schering-Plough told investors that the FDA is in search of additional trial data and product labeling information and that it expects to satisfy the agency's request during this quarter.
"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.
- check out Schering's release