Genmab - Janssen's Darzalex Wins Positive Opinion In Europe For Two New Indications

by Vandana Singh, Benzinga Editor
May 21, 2021 3:49 PM | 1 min read |
  • Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion and recommended granting marketing authorization to Genmab A/S GMAB and its partner Janssen Biotech Inc's Darzalex (daratumumab) subcutaneous for amyloidosis.
  • The opinion is for daratumumab in combination with bortezomib, cyclophosphamide, and dexamethasone to treat adult patients with newly diagnosed systemic light-chain amyloidosis.
  • The CHMP also issued a positive opinion recommending Darzalex SC in combination with pomalidomide and dexamethasone in pre-treated adult multiple myeloma patients.
  • Price Action: GMAB shares are up 1.76% at $39.36 during the market session on the last check Friday.
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BiotechNewsHealth CareGeneralamyloidosisBriefsEuropean Medicines Agency (EMA)
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