Wednesday, September 23, 2020 4:25:37 AM
Relief partner requests admission for corona medication
NeuroRx seeks emergency clearance for RLF-100. It should be used in corona patients in critical condition.
The application is based on a case-control study, in which patients' disease progression is compared
The application is based on a case-control study in which the disease processes of patients treated with either RLF-100 or standard therapy were compared. (Image: Gaetan Bally / Keystone)
(AWP) The research partner of the Geneva biotech company Relief Therapeutics ( RLF 0.578 10.31% ) , NeuroRx, has submitted an authorization application for the drug RLF-100 (Aviptadil) in the USA. RLF-100 is to be used as an emergency medication in corona patients in critical condition.
NeuroRx filed a permit application with the US Food and Drug Administration (FDA), which announced relief on Wednesday. With RLF-100, Corona patients are to be treated in intensive care units, for which all permitted treatment methods are exhausted.
The application is based on a case-control study in which the disease processes of patients treated with either RLF-100 or standard therapy were compared. The treatment with RLF-100 showed a three-fold better result in terms of survival, recovery from respiratory failure and other parameters.
However, the treatment also has its drawbacks: Thus, in the tests in two patients treated with Aviptadil, a hypotension - ie low blood pressure - was observed. However, these have been successfully treated with vasopressors. Diarrhea was observed in four of the 21 patients treated with Aviptadil and in three of the 30 control patients.
The permit for the use of RLF-100 as an emergency medicine addresses the same patient population that will be treated in the framework of the "Expanded Access" protocol approved by the FDA, the communication continues. Many patients who may have benefited from this "expanded access" did not receive access to clinical trials, said NeuroRx chief Jonathan Javitt, according to the announcement. All too often, these are patients with lower socioeconomic status.
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