EMA’s CHMP backs six new products in January
Sanofi’s Rezurock belumosudil gets conditional marketing authorization on re-exam
At its January meeting, CHMP recommended six new drugs and vaccines, including a rare post-reexamination reversal, backing Sanofi’s ROCK2 inhibitor Rezurock belumosudil to treat chronic graft-versus-host disease (GvHD) in ages twelve and up.
CHMP’s Rezurock recommendation is for conditional marketing authorization. Sanofi (Euronext:SAN; NASDAQ:SNY) received FDA approval of the drug in 2021 for chronic GvHD after failure of at least two prior lines of therapy. ...
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BCR-ABL tyrosine kinase (BCR-ABL)
Complement receptor 5A (C5AR1) (C5AR) (CD88)
Cytochrome P450 17 alpha-hydroxylase/C17, 20 lyase (CYP17) (CYP17A)
Estrogen receptor 1 (ER) (ESR1)
Fungal cytochrome P450 C-14 alpha demethylase (fungal CYP51)