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So there are currently 4 Covid Treatments currently under rolling review at EMA;
Bamlanivimab and etesevimab
Regdanvimab
REGN-COV2 (casirivimab / imdevimab)
Sotrovimab
We have been told they wish to name 5 of the most promising treatments so you expect 4 will be the above. Could SNG001 be the other one? My bet it's more likely we will fall into the other 5 they wish to start the rolling reviews for year end as this will match with our P3 trial data. We should find out 1st July.
www.ema.europa.eu/en/events/ema-regular-press-briefing-covid-19-1
Bamlanivimab / etesevimab are one of the 4 monoclonal antibodies under rolling review by EMA so this puts EMA in an awkward position is they are about to include this as one of if the 5.
www.fiercepharma.com/pharma/lilly-s-covid-antibody-combo-halted-nationwide-dealing-huge-blow-to-blockbuster-program?mkt_tok=Mjk0LU1RRi0wNTYAAAF94y4psS0F8RyZgnDxwy8kosy8MyCFx19iIats6osjdcfOQePcyC1ZsOypXwxc3M3YUcWhXJoB95AIptQ3gE755zCwCjMq8Qy2ZN9AKcSqVUwvs7s1xAQ&mrkid=166982449
Pmjh I would love it if you're correct. I just think October for approval is to early. I think we are much more likely to be one of the other 7 treatments they want to include for Rolling reviews for year end 2021. We haven't got long until we find out.....
Pmjh you're correct it's not confirmed but it's highly likely. The EMA are currently doing rolling reviews for 3 MABs with the aim of approval for October. Now they have mentioned another MAB so I think they will make up at least 3 of the 5. Now it does leave 2 others and 1 could be synairgen but feel it's a little to early even if they have access to the Activ 2 trial since it's still P2 (less than 220 patients).
3 of the 5 are monoclonal antibodies
Currently, the EMA is conducting rolling reviews of three COVID-19 therapeutics building on monoclonal antibodies and seven rolling reviews for promising COVID-19 therapeutics are expected to start by the end of 2021."
"Work towards granting an authorisation for three new COVID-19 therapeutics by October 2021. Subject to research and development outcomes, start seven rolling reviews for promising COVID-19 therapeutics (EMA) by end 2021."
htTps://ec.europa.eu/info/sites/default/files/communication-strategy-covid-19-therapeutics_en.pdf
Doesn't look like we are part of the 5
"In terms of therapeutics, four monoclonal antibodies with antiviral activity have received a scientific opinion for emergency use (prior to full authorisation). They are undergoing rolling review and we hope to have at least one or two authorised by 3Q 2021. They showed efficacy in the early treatment of COVID-19 in patients not requiring supplementary oxygen but at risk of progressing to more severe disease. There are also other products under assessment, for example Alumiant, a repurposed medicine, which has showed some early signs of efficacy, the data is currently under review."
htTps://www.ema.europa.eu/en/documents/minutes/meeting-summary-european-medicines-agency-ema-patients-consumers-pcwp-healthcare-professionals-hcpwp_en.pdf