The U.S. Food and Drug Administration has given “Orphan Drug Designation” to the new mesothelioma UV1 cancer vaccine manufactured by Ultimovacs. The designation gives the manufacturer certain incentives, such as tax credits and market exclusivity, to help ensure continued research and development of vaccines that treat rare diseases and conditions.
At Bailey Cowan Heckaman, we provide experienced representation for mesothelioma victims nationwide. Our lawyers have secured millions of dollars on behalf of clients who have been diagnosed with asbestos-related illnesses such as mesothelioma or who have lost loved ones to the devastating disease. If you or a loved one has been diagnosed with mesothelioma, contact our office at (888) 367-7160 to schedule a free, no-obligation consultation.
Orphan drug designation is a designation given by the U.S. Food and Drug Administration (FDA) to incentivize drug manufacturers to continue to research treatments and vaccines for rare illnesses or conditions.
When a drug manufacturer receives ODD, they are given multiple incentives to continue their research, including:
Without orphan drug designation, drug manufacturers have little incentive to continue to research and develop drugs that help to “prevent, diagnose, or treat'' rare diseases. While orphan drug designation is not the same as the FDA’s approval process, it does help to promote clinical trials and other research related to certain conditions.
The Ultimovacs UV1 vaccine is currently in clinical trials. It was developed to create an immune response against the body’s proliferation of certain cancer cells in people with malignant pleural mesothelioma. Malignant pleural mesothelioma is the leading type of malignant mesothelioma.
Approximately 75% of all mesothelioma cases are pleural mesothelioma. The only known cause of pleural mesothelioma is exposure to asbestos. It can take years after exposure for symptoms related to mesothelioma to become apparent. There are currently few therapeutic options to treat this dangerous and deadly disease. If you have been diagnosed with an asbestos-related disease, contact our mesothelioma lawyers today.
The UV1 vaccine was given orphan drug designation by the U.S. Food and Drug Administration because of the results of clinical trials conducted by the Norway-based company. The mesothelioma vaccine is currently in Phase II studies that will be presented at an international conference.
Were you or a loved one diagnosed with mesothelioma or another asbestos-related condition? We can help determine if you have a valid claim for damages. We have secured millions of dollars on behalf of mesothelioma victims nationwide. Contact our office at (888) 367-7160 to schedule a free, no-obligation case evaluation.
At Bailey Cowan Heckaman, we are dedicated, passionate advocates who will not give up until justice is served. Do not trust your case to a less experienced firm. Mesothelioma is a dangerous, preventable disease. If you have been diagnosed with the condition, you may be entitled to compensation. Call now to get started.