Vanda Pharmaceuticals Faces Setback in Europe
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) has suffered a setback in Europe where a regulator has declined to approve use of its oral drug to treat adult schizophrenia.
The Washington-based drug developer said the European Medicines Agency’s Committee for Medicinal Product for Human Use barred sale of the oral iloperidone tablet Fanaptum in the European Union. The CHMP held that the benefits of Fanaptum “did not outweigh its risks.”
Vanda said it intends to appeal the decision and seek a review of the panel’s judgment.
Founded in 2003, Vanda focused on development of drugs to treat central nervous system disorders.