發稿單位：(PEI)Paul Ehrlich Institut德國聯邦疫苗藥物研究機構
發稿時間：2020/03/31
撰 稿 者：PEI
原文連結：https://reurl.cc/pd3XMZ
1.目前進行到2/3期試驗
2.原本是作為類風濕關節炎的藥物
3.目前還沒找到相關結果報告
M大提供相關文章https://reurl.cc/8Gv7NR
https://imgur.com/nE3LEiy
英文新聞原文:
Therapy against COVID-19 Symptoms under Development - Clinical Trials fo
r Sarilumab authorised
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.
Monoclonal Antibodies (Source: GettyImages)
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.
Sarilumab
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.