Saudi Food and Drug Authority typically responds to Breakthrough Medicine Designation applications within approximately 60 days
CEL-SCI Corporation announced it has completed its Breakthrough Medicine Designation application for Multikine for submission to the Saudi Food and Drug Authority in Saudi Arabia. Multikine is an immunotherapy administered before surgery as a treatment for newly diagnosed previously untreated head and neck cancer.
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The Breakthrough Designation Application is expected to be formally submitted to the SFDA on CEL-SCI’s behalf within the next few weeks by the Company’s prospective Saudi partner, one of the country’s premier pharmaceutical and healthcare companies. According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days.
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“We are very excited that Multikine could become available to patients in Saudi Arabia as early as this summer,” stated CEL-SCI CEO Geert Kersten. “Based on our recent meeting with the SFDA, we are hopeful for a positive response. In the meeting the SFDA provided guidance and gave encouragement for seeking approval for Multikine in head and neck cancer. Our belief is that Multikine meets all requirements for Breakthrough Medicine Designation as published by the SFDA. Together with our prospective local partner, we are hopeful that we will be able to help patients in Saudi Arabia.”
Under the SFDA’s new Breakthrough Medicine Designation program, Multikine would immediately become available for patient access and reimbursement upon it being granted Breakthrough Medicine Designation. Head and neck cancers constitute approximately 5% of all cancer cases in Saudi Arabia.
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Source – businesswire
