Roche, AbbVie, Bristol-Myers Are Latest To Win European Medicines Agency's CHMP Positive Opinion

  • European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval of Roche Holdings AG’s RHHBY Enspryng, AbbVie Inc’s ABBV Venclyxto (venetoclax), and Bristol-Myers Squibb Co’s BMY Opdivo Plus Yervoy and Onureg.
  • The final decision is expected to be delivered during the first half of 2021.
  • Enspryng has been recommended to treat neuromyelitis optica spectrum disorder (NMOSD) in patients over 12 who are anti-aquaporin-4 IgG (AQP4-IgG) seropositive.
  • It is a humanized monoclonal antibody designed to target and inhibit interleukin-6 (IL-6) receptor activity, believed to play a key role in the inflammation associated with NMOSD.
  • CHMP backed Venclyxto in combination with hypomethylating agents to treat adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy. 
  • CHMP has recommended approval of Onureg as maintenance therapy in adult patients with acute myeloid leukemia who achieved complete remission following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT).
  • EMA’s advisory issued a positive opinion for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable malignant pleural mesothelioma. 
  • Price Action: BMY shares are down 0.11% at $66.25, ABBV shares are up 1.37% at $111.56, while RHHBY shares are down 0.18% at $42.45 in the market trading hours on the last check Friday.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsHealth CareFDAGeneralBriefsEuropean Medicines Agency (EMA)leukemiaNMOSD
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!