The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines has granted the authorisation of a combined Phase 2/3 study of Sarilumab (trade name: Kevzara). A favourable opinion was also granted by the ethics committee. Sarilumab is already used in the treatment of rheumatoid arthritis. The aim of the clinical trial is to gain insights in the safety and efficacy of Sarilumab in the treatment of serious COVID-19 diseases.
Effective therapeutics are urgently needed in the treatment of serious COVID-19 diseases and are currently tested both in treatment attempts and in clinical trials. Distinctions must be made between the following active ingredients: (1) those which reduce the replication of the virus by inhibiting its function, (2) those which inhibit the transmission of the virus from cell to cell in the body of infected individuals, and (3) those which deactivate the damaging mechanisms triggered by CoV-2 in the body of the infected individual. Up to now, existing active ingredients and active ingredients authorised for the treatment of other diseases (indications) are tested for the treatment of Covid-19. This is called "repurposing". According to the World Health Organisation (WHO), academic and industrial developers are currently working on more than 50 active ingredient candidates. The Paul-Ehrlich-Institut supports the development of biomedicines for the treatment of Covid-19. In doing so, it focusses on immunomodulatory antibodies.
In a scientific advice setting, The Paul-Ehrlich-Institut offers the option to developers of medicines to inform themselves on the regulatory requirements for a concrete clinical trial in advance, to discuss them, and to define a targeted path for development. The transfer of knowledge contributes to performing the authorisation procedures for clinical trials efficiently and without any time delays. Based on the extensive preparation for the talks and the experience gained so far for Sarulimab with other indications, the Paul-Ehrlich-Institut was able to grant the authorisation for the clinical trial for Sarilumab in the treatment of COVID-19 within one day.
The active ingredient Sarilumab (trade name: Kevzara) is a monoclonal antibody targeted against the interleukin-6 receptor which has been granted the marketing authorisation for the treatment of medium to serious active rheumatoid arthritis and shall now be tested in the treatment of COVID-19. Interleukin-6 may play a role for the excessive inflammatory reaction of the body caused by CoV-2, which affects organs of COVID-19 patients including the lung. Sarilumab is an immunomodulator and is able to block the mechanisms triggered by interleuin-6 by inhibiting the binding of interleukin-6 to the interleukin-6 receptor.
Updated: 31.03.2020
