CHMP recommendations include Ajovy, Vizimpro, Humira biosimilars
EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Ajovy fremanezumab, Vizimpro dacomitinib and two Humira biosimilars. CHMP also backed an expanded label for Forxiga dapagliflozin to include Type I diabetes.
The agency recommended Ajovy from Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) to prevent migraine. FDA approved the mAb targeting the CGRP ligand in September...
BCIQ Company Profiles
BCIQ Target Profiles
Calcitonin gene-related peptide (CGRP)
Epidermal growth factor receptor (EGFR) (ErbB1) (HER1)
Epidermal growth factor receptor 2 (HER2) (EGFR2) (ErbB2) (neu)
Epidermal growth factor receptor 4 (EGFR4) (HER4) (ErbB4)
FMS-like tyrosine kinase 3 (FLT3) (CD135)
Platelet derived growth factor receptor A (PDGFRA) (PDGFR2) (CD140A)