The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Emergent BioSolutions Inc.'s humanized anti-CD37 mono-specific protein therapeutic, TRU-016, for the treatment of chronic lymphocytic leukaemia (CLL) patients. This designation is given to drugs and biologics that are being developed to treat rare medical conditions, specifically those affecting fewer than 200,000 persons in the US TRU-016 is being developed in collaboration with Abbott.
“Receiving FDA Orphan Drug Designation for TRU-016 underscores the medical need in treating B-cell malignancies like CLL,” said Scott C Stromatt, MD, senior vice president and chief medical officer, Emergent BioSolutions. “Emergent is pleased to receive this designation and is committed to advancing product candidates that improve the lives of patients suffering from diseases like CLL.”
The FDA Orphan Drug Designation of TRU-016 provides for a number of potential benefits, including a seven-year period of marketing exclusivity in the US, reduced or waived regulatory fees, certain tax credits, and additional regulatory assistance and access to specific grants programmes for research and development initiatives.
TRU-016 is currently being evaluated in multiple human phase I clinical studies for the treatment of CLL and non-Hodgkin’s lymphoma (NHL).
Emergent BioSolutions protects and enhances life by developing and manufacturing vaccines and therapeutics that are supplied to healthcare providers and purchasers for use in preventing and treating disease.