On January 9, 2023 Secura Bio, Inc. (Secura Bio) – (www.securabio.com), an integrated pharmaceutical company dedicated to the worldwide development and commercialization of impactful oncology therapies, reported that the European Commission (EC) issued an Orphan Drug Designation for duvelisib for the treatment of patients with peripheral T-cell lymphoma (PTCL) (Press release, Secura Bio, JAN 9, 2023, View Source [SID1234626127]). Duvelisib was previously granted orphan drug designation by the United States Food and Drug Administration.
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Orphan Drug Designation in the EU is granted by the EC based on a positive opinion issued by the European Medicines Agency Committee for Orphan Medicinal Products. It is intended to encourage the development of drugs that may provide significant benefit to patients suffering from rare, life-threatening diseases. If approved for marketing, this designation will provide ten years of marketing exclusivity and other special incentives for sponsors, including eligibility for protocol assistance and possible exemptions or reductions in certain regulatory fees.
Duvelisib is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first US-approved dual inhibitor of PI3K-delta and gamma pathways, which are involved in the proliferation and sustenance of malignant cells. Duvelisib was fully approved by the US Food and Drug Administration in September 2018 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies.
"This Orphan Drug Designation recognizes the significant unmet need in patients with PTCL, especially those with relapsed/refractory disease. This patient group has very limited therapeutic options and duvelisib may offer a new choice of therapy." Said Dr. David Sidransky, Clinical Advisor to Secura Bio.
"Secura Bio is dedicated to developing duvelisib for the treatment of patients with difficult-to-treat cancers, which includes relapsed/refractory PTCL. We are investing significant corporate resources in this endeavor and hope to see new treatment options brought to the market which may benefit patients, such as those with relapse/refractory PTCL." Said Joseph M. Limber, President and CEO of Secura Bio.