Trovagene announced that the European Commission (EC) has endorsed the positive opinion of the Committee for Orphan Medicinal Products (COMP) and has granted Orphan Drug Designation (ODD) for Onvansertib, a first-in-class, 3rd generation, oral and highly-selective Polo-like Kinase 1 (PLK1) inhibitor, for the treatment of patients with Acute Myeloid Leukemia (AML).
“The European Commission’s decision to grant orphan drug designation to Onvanersertib for the treatment of AML is a key regulatory milestone that will further facilitate our clinical development program,” said Dr. Thomas Adams, Executive Chairman of Trovagene. “We believe that Onvansertib, which previously received orphan drug designation for the treatment of AML from the FDA in the U.S., has the potential to provide a much-needed new therapeutic option for patients who are ineligible for induction therapy or who have relapsed/refractory disease.”
Orphan drug designation by the EC provides regulatory and financial incentives to Trovagene, including reduced fees during the product development phase, direct access to centralized marketing authorization in the EU, and 10-year market exclusivity following product approval.
The COMP, a committee of the EMA, adopted a positive opinion on the granting of orphan drug designation to Onvansertib in July, 2018, stating that “Onvansertib will be of significant benefit to those affected by AML.” Following the process set forth by the EMA, the opinion of the COMP was subsequently submitted to the European Commission (EC) for formal endorsement. The EC decision to endorse the positive opinion issued by the COMP was received by Trovagene on August 28, 2018.