FDA Grants Orphan Drug Designation to Debio 1143
News Jun 02, 2016
Debiopharm International SA (Debiopharm) has announced that the FDA Office of Orphan Products Development (OOPD) has granted Orphan Drug Designation to Debio 1143 for treatment of Ovarian Cancer. Orphan Drug Designation by the FDA provides regulatory and financial incentives to develop therapies for life-threatening or chronically debilitating conditions affecting fewer than 200 000 people in the US, or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug, and for which no satisfactory treatment is available.
Debio 1143 is an oral, small molecule inhibitor of IAPs (Inhibitor of Apoptosis Proteins) with a dual pro-apoptotic and immunomodulatory mode of action developed as a potent chemo/radio-sensitizer in oncology. Further to the encouraging signs of efficacy seen in clinical phase I and supported by this significant regulatory milestone, Debiopharm will soon expand the clinical development of this therapy to patients with ovarian cancer.
"Obtaining orphan designation for Debio 1143 in the United States is an important regulatory milestone", stated Peggy Lipp, Director, Regulatory Affairs, Business Intelligence & Market Access, Debiopharm International S.A. "It speaks to the need for new treatment options in this chronically debilitating and life threatening condition and the potential role of Debio 1143's mode of action. This orphan drug designation is a proof of our commitment to developing innovative therapies for oncology patients".