Oncoheroes Biosciences, member of CataloniaBio & HealthTech, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to dovitinib for its use in treating osteosarcoma.
The U.S. FDA has established initiatives aimed at incentivizing pharmaceutical companies to pursue drug development for rare diseases, which are characterized as conditions impacting fewer than 200,000 individuals in the U.S. at the time of designation. Following the enactment of the Orphan Drug Act in 1983, the FDA has granted Orphan Drug Designations (ODD) and subsequently approved the release of numerous drugs tailored to treat such rare diseases.
Under the Orphan Drug status, Oncoheroes will qualify for various development incentives, including a tax credit on expenditures incurred in clinical studies, exemption from filing fees such as the user fee, substantial cost savings, or eligibility for a research grant awarded by the FDA. Being granted orphan designation does not modify the standard regulatory requirements to obtain marketing approval.
“We are thrilled to have received another favorable notice from the FDA. This underscores the imperative demand for better treatments for children and adolescents with osteosarcomas,” stated Cesare Spadoni, Oncoheroes’ Founder and COO. “We anticipate that this excellent news will expedite the drug's clinical development, benefiting not just osteosarcoma patients but also other pediatric solid tumors given the design of dovitinib's Phase 1/2a clinical trial, which has been recently allowed to proceed by the FDA”.
In September 2022, dovitinib was also granted the Rare Pediatric Disease Designation (RPDD), making Oncoheroes eligible for a fast-track review and for a Priority Review Voucher (PRV) that is fully transferable to other sponsor companies and has a current average market value of $100 million.
Comments