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MarketScreener Homepage  >  Equities  >  Euronext Paris  >  Sanofi SA    SAN   FR0000120578

SANOFI SA

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Sanofi : receives positive CHMP opinion for Sarclisa for the treatment of relapsed and refractory multiple myeloma

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03/30/2020 | 08:40am EDT

Paris - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Sarclisa (isatuximab).

The CHMP recommends Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on the last therapy.

The European Commission (EC) will review the CHMP recommendation and a final decision on the Marketing Authorisation Application for Sarclisa in the E.U. is expected in the coming months. Sarclisa has not been approved for commercial use in the E.U. Sarclisa was approved in the US on March 2 in combination with pomalidomide and dexamethasone (pom-dex) for the treatment of adults with RRMM who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.

'Relapsed and refractory multiple myeloma is a complicated disease that continuously develops resistance to treatment, creating a significant need for continued innovation,' said John Reed, M.D., Ph.D., Sanofi's Global Head of Research & Development. 'This positive CHMP opinion for Sarclisa brings us closer to our ambition to deliver a new treatment option for patients in Europe with relapsed and refractory multiple myeloma.'

Sarclisa Phase 3 Study Results in Patients with RRMM

The CHMP positive opinion is based on data from ICARIA-MM, the first randomized Phase 3 trial to evaluate an anti-CD38 monoclonal antibody (mAB) in combination with pom-dex. In the ICARIA-MM study, Sarclisa added to pom-dex (Sarclisa combination therapy; n=154) demonstrated a statistically significant improvement of progression free survival (PFS) with a median PFS of 11.53 months compared to 6.47 months with pom-dex alone (n=153; HR 0.596, 95% CI: 0.44-0.81, p=0.0010). Sarclisa combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone (60.4% vs. 35.3%, p

(C) 2020 Electronic News Publishing, source ENP Newswire

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Financials (EUR)
Sales 2020 37 449 M
EBIT 2020 10 105 M
Net income 2020 5 893 M
Debt 2020 16 154 M
Yield 2020 3,73%
P/E ratio 2020 18,7x
P/E ratio 2021 16,6x
EV / Sales2020 3,31x
EV / Sales2021 3,11x
Capitalization 108 B
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NameTitle
Paul Hudson Chief Executive Officer & Director
Serge Weinberg Chairman
Jean-Baptiste Chasseloup de Chatillon Chief Financial Officer & Executive Vice President
Ameet Nathwani Chief Medical & Digital Officer
John C. Reed EVP & Global Head-Research & Development
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