US FDA approvals for Signifor, raxibacumab and Iclusig

In a flurry of activity from the US Food and Drug Administration on Friday, the agency – which looks likely to set a record of new drug approvals in the current year, issues positive rulings for three more, one of which was three months ahead of expectations.

First, the FDA approved Swiss drug major Novartis' Signifor (pasireotide diaspartate) injection for the treatment of Cushing’s disease patients who cannot be helped through surgery. In April 2012, the European Commission approved Signifor for the treatment of adult patients with Cushing's disease for whom surgery is not an option or for whom surgery has failed. Other worldwide regulatory filings for pasireotide for this use are also underway, said Novartis.

“Although surgery tends to be first line therapy to treat Cushing’s disease, Signifor is a new treatment option for patients when surgery hasn’t worked or isn’t an option,” said Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.