FDA Grants Orphan Drug Designation to New Mesothelioma Drug
Italian drug manufacturer Fidia Farmaceutici has announced that its anticancer drug ONCOFID®-P has received a coveted orphan drug designation from the U.S. Food and Drug Administration. This move will provide the company with several development incentives, including tax credits for qualified clinical testing and eligibility for seven years of market exclusivity once its product receives full FDA approval.
ONCOFID®-P Increases Concentration of Medication within Mesothelioma Cells
ONCOFID®-P combines the drug paclitaxel with hyaluronic acid, allowing the medication to bind to mesothelioma cells, which express the HA receptor CD 44. This binding increases the concentration of the cancer drug within the cancer cells and boosts its effectiveness. The combination drug has already proven safe and effective in the treatment of bladder cancer.
In preliminary testing, the use of ONCOFID®-P makes the mesothelioma cells much more susceptible to treatment than paclitaxel alone and results in improvements in both survival and tumor mass reduction while eliminating systemic exposure and subsequent side effects According to Professor Antonio Rosato, Professor at the University of Padua and Director of the Immunology and Molecular Oncology Diagnostics Unit and Deputy Scientific Director at the Istituto Oncologico Veneto IRCCS, “Oncofid-P represents a very important step forward for the treatment of this serious disease.”
Rarity of Mesothelioma Diminishes Economic Value of Scientific Inquiry
Malignant mesothelioma is one of the rarest illnesses in the world, and this fact adds to the challenges of finding a cure. Because so few people are faced with this fatal asbestos-related disease, drug companies have little financial incentive for dedicating resources to research. The tremendous cost of developing a drug offers little opportunity to recoup costs, let alone to make a profit.
To encourage innovators to invest in scientific inquiry despite the cost, the U.S. Food and Drug Administration has created the Orphan Drug Designation that provides special incentives specifically for rare diseases like malignant mesothelioma. This designation provides incentives that make the much-needed research economically worthwhile.
Despite the challenges, researchers are working every day towards finding a cure for malignant mesothelioma. If you or someone you love has been diagnosed with this rare and deadly disease and you need information, contact the Patient Advocates at Mesothelioma.net today at 1-800-692-8608.
Written by Terri Oppenheimer
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