Policy & Regulation
USFDA approves EMD Serono's investigational new drug application for Coronavirus pneumonia
26 June 2020 -

United States Food and Drug Administration (USFDA) has approved US-based EMD Serono's investigational new drug application for M5049 intended for the treatment of patients with Covid-19 pneumonia, it was reported on Thursday.

The firm is to start a Phase II randomised, controlled clinical study assessing the safety and efficacy of M5049 in subjects. The phase two study results will be revealed around the end of 2020.

The product is a potentially first-in-class small molecule that inhibits the activation of Toll-like receptor (TLR)7 and TLR8, two immune sensors that detect single-stranded RNA from viruses including SARS-CoV-2. It will be investigated in a randomised, placebo-controlled study at sites in the United States and Brazil in around 150 subjects.



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