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RELIEF THERAPEUTICS Holding SA a biopharmaceutical company seeking to provide patients therapeutic relief from serious diseases with high unmet need, reported today that it has received scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) relating to its lead investigational drug, RLF-100(TM) (aviptadil), for the treatment of respiratory deficiency due to severe COVID-19. The guidance, which was provided in the context of a recent meeting that Relief held with the MHRA, included advice on the appropriate pathway for submission of an application for conditional marketing approval (CMA) for the intravenous formulation of RLF-100, subject to provision of all data from the U.S. Phase 2b/3 study conducted by Relief’s collaboration partner, NeuroRx, Inc.
("NeuroRx") According to the MHRA, a CMA through rolling review or expedited review process would be an appropriate pathway to ensure speedy access to beneficial treatments for patients infected with COVID-19. A rolling review allows the MHRA to start review of various sections of a submission as they are completed by Relief and provided to the MHRA.
Relief also reported today that it has held discussions with the European Medicines Agency (EMA) pertaining to the regulatory path forward for RLF-100 in the European Union. Relief has informed EMA that it will proceed with further dialogue with the MHRA once it has compiled critical information related to the study conduct, clinical data and the drug product.
Relief also reported that, to date, NeuroRx has not provided it with all of the data from its U.S. Phase 2b/3 study evaluating intravenously administered aviptadil for the treatment of respiratory failure in critically ill patients with COVID-19. There can be no assurance that NeuroRx will provide the required information.
