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Philadelphia Mesothelioma Attorneys Discuss FDA’s Orphan Drug Program

March 27, 2012 – Although there is presently no cure for mesothelioma cancer, a deadly disease linked exclusively to asbestos exposure, researchers worldwide continue to search for new treatments and therapies in the hope that the progression of the disease can be stopped in its tracks. Research for a cure for malignant mesothelioma is difficult because the disease can take 20 years or more to surface. Furthermore, because only approximately 3,000 people each year are diagnosed with the disease, the small number of cases available for study makes it difficult to meet FDA testing requirements. The drug companies find it cost prohibitive to pursue research and testing.

The FDA’s Orphan Drug Designation Program provides hope to victims of serious diseases, such as mesothelioma, for potentially effective treatments that would not otherwise get the funding and FDA approval needed for further research. The Program provides incentives for drug companies to develop products for rare diseases – those diseases that affect fewer than 200,000 people in the United States, or affect more than 200,000 people but whose treatment drug sales are not expected to recover the costs of developing and marketing the drug.  The goal of the Orphan Drug Program is to find preventative treatments and cures for these uncommon diseases.

“Orphan Drug” status permits drug developers to use smaller testing samples to achieve FDA authorization to continue research.  This status also gives a drug company unique tax incentives and a complete seven year period of exclusive rights against generic drug rivals. The Program has fostered the development and marketing of more than 350 drugs and products for rare diseases since 1983.  In contrast, in the ten years prior to 1983, fewer than 10 such drugs were made available to victims of rare diseases.

New Mesothelioma Drug Granted “Orphan Drug” Status

Since Mesothelioma is an “Orphan Disease” under the Program, it is noteworthy when a new treatment for mesothelioma is granted an Orphan Drug designation, allowing its developers to focus on the advancement of the drug rather than the costs in time and money. For example, a new mesothelioma drug, CBP501, developed by the Japanese drug company CanBas and recently awarded Orphan Drug status by the FDA, offers new hope in the treatment of the deadly disease. The drug is in the early stages of testing, but it is believed that the drug will be effective in treating asbestos-related cancer when it is combined with traditional chemotherapy. Its Orphan Drug designation will ensure further research and testing.

Contact Philadelphia Mesothelioma Attorneys at the Shein Law for More Information

The Philadelphia mesothelioma attorneys at Shein Law are diligent in staying informed on the latest asbestos-related cancer treatments and drug developments. We believe this is the best way to serve our clients and support their struggle with the deadly disease. Throughout our many years of representing victims and their families who have fallen victim to mesothelioma, we have strived to provide not only quality legal representation, but also offer useful information and resources to utilize in their day-to-day efforts to live with the disease.  Call our Philadelphia office today to speak with one of our experienced, knowledgeable and compassionate attorneys.

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