This approval is for a larger subset of melanoma patients than was requested, and includes melanoma in stages IIb through IV.
Orphan drug status is granted by the FDA to encourage biotechnology and pharmaceutical companies to develop drugs that demonstrate promise for the treatment of rare diseases, which affect fewer than 200,000 people in the US. Orphan drug status will afford PhiloGene seven years of marketing exclusivity for the drug, once the FDA ultimately approves VEGFb.
Miriam Mangelus, CEO of PhiloGene, said: “The orphan drug approval will enable us to accelerate the process to make VEGFb available to treat patients with advanced malignant melanoma. This in turn will help the company to develop VEGFb for additional cancers, retinal disorders (wet macular degeneration and diabetic retinopathy), and other diseases.”