Relief Therapeutics Holdings AG / Key word(s): Miscellaneous
23.09.2020 / 07:02
Relief partner NeuroRx submits request for Emergency Use Authorization for RLF-100(TM) (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy
Emergency Use Authorization request targets the same population as is currently permitted under FDA Expanded Access Protocol
Geneva, Switzerland, and Radnor, PA, September 23, 2020 - RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company") and NeuroRx, Inc. today announce that NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100(TM) aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments. RLF-100 is being developed by NeuroRx as part of a global partnership with Relief. The submission is based on a case-control study that compared patients who were treated with RLF-100(TM) (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with RLF-100(TM) demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement. Hypotension was seen in two aviptadil patients and was successfully managed with pressors. Diarrhea was seen in 4/21 aviptadil-treated patients and 3/30 control patients. The results have been submitted to a peer-reviewed journal.
"The EUA application covers the same type of patients whom FDA has already allowed to receive treatment under the Expanded Access protocol authorized by the Agency in July. Tragically, we have found that many patients who might benefit from the Expanded Access protocol are hospitalized in centers that do not allow patients access to investigational drugs," said Jonathan Javitt, MD, MPH, Chairman and CEO of NeuroRx, "Our staff is working around the clock to address requests for RLF-100(TM) under the appropriate mechanism. All too often, patients of color and those of lower socioeconomic status are denied access."
FDA's guidance to industry identifies the criteria for EUA as safe and "may be effective," in contrast to the far more stringent requirement of "safe and effective" required for traditional drug approval. EUA may only be granted in circumstances where the Secretary of Health and Human Services has declared a Public Health Emergency, as is true in the COVID-19 pandemic.
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: "We continue to work tirelessly with our partner NeuroRx to bring this potentially life-saving drug to patients afflicted with severe complications of COVID-19 infection as quickly as possible. The pursuit of EUA status is a crucial component of this effort."