SYDNEY, September 9, 2020 / PRNewswire / – Clarity Pharmaceuticals, a clinical-stage radiopharmaceutical company focused on the treatment of major diseases, is pleased to announce that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPDD) status has awarded 64Cu-SARTATE ™, a diagnostic agent for the clinical treatment of neuroblastomas.
DR Alan Taylor, Executive Chairman of Clarity, commented, “We are very pleased to have RPDD status for the diagnostic use of SARTATE ™ in children with neuroblastoma, shortly after Clarity’s RPDD for the treatment of neuroblastoma 67Cu-SARTATE ™ for therapeutic use, announced on 3approx from June 2020. “
The FDA defines a “rare pediatric disease” (RPD) as a serious or life-threatening condition that primarily affects people aged 18 years or younger and affects fewer than 200,000 people The United States. The program aims to facilitate the development of new drugs and biologics for the prevention and treatment of RPD.
Neuroblastomas are most common in children under the age of 5 and occur when the tumor grows and causes symptoms. It is the most common cancer diagnosed in the first year of life and is responsible for about 15% of childhood cancer mortality. High-risk neuroblastoma accounts for about 45% of all neuroblastoma cases. Patients with high-risk neuroblastoma have the lowest 5-year survival rates at 40-50%.
Following FDA marketing approval of 64Cu-SARTATE ™ for neuroblastoma with RPD marking, Clarity would be entitled to receive a tradable Priority Review Voucher (PRV). The PRV shortens the FDA review deadline for a new drug application (NDA) for another product to an accelerated period of six months, which is of great benefit to drug developers. The voucher, when issued, can be sold or transferred to another company. Previously, PRVs were used for between $ 67.5 million and $ 350 million, with Merck taking the most recent PRV from Lumos Pharma for a value of. buys $ 100 million in July 2020.
“With 67Cu-SARTATE ™, a therapeutic agent for the clinical treatment of neuroblastomas, has also been awarded RPDD status“Clarity may be eligible for two Priority Review Vouchers if both treatments receive FDA approval,” commented Dr. Taylor.
“We have received incredibly strong support from our staff and consultants in the development of SARTATE ™ for neuroblastoma, and we look forward to the results of our US study at the Memorial Sloan Kettering Cancer Center.”. It is evident that there is a great unmet need in the treatment and management of this devastating disease and we aim to improve outcomes for this important patient population with both the diagnostic and therapeutic uses of SARTATE ™, “said Dr. Taylor.
- Nadja C. Colon and Dai H. Chung 2011, “Neuroblastoma”, Advances in Pediatrics,https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3668791/>
- Valeria Smith and Jennifer Foster 2018, Evaluation of high risk neuroblastoma treatment,https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6162495/>
- Lumos Pharma Announces Sale of Priority Review Voucher July 27, 2020,https://www.globenewswire.com/news-release/2020/07/27/2068182/0/en/Lumos-Pharma-Announces-Sale-of-Priority-Review-Voucher.html>
- Clarity Pharmaceuticals announces that 67Cu-SARTATE ™ has been classified as a rare pediatric disease by the US FDA for the treatment of neuroblastoma 3rd June 2020,https://www.claritypharmaceuticals.com/news/rpdd/>
- ClinicalTrials.gov ID: NCT04023331https://clinicaltrials.gov/ct2/show/NCT04023331>
Clarity is a personalized medicine company focused on the treatment of serious illnesses. The company is a leader in innovative radiopharmaceuticals and develops targeted therapies for the treatment of cancer and other serious diseases in adults and children.
SOURCE Clarity Medicines