U.S. Markets open in 5 hrs 18 mins
  • S&P Futures

    4,167.50
    +7.50 (+0.18%)
     
  • Dow Futures

    34,169.00
    +51.00 (+0.15%)
     
  • Nasdaq Futures

    13,535.50
    +44.50 (+0.33%)
     
  • Russell 2000 Futures

    2,245.90
    +9.30 (+0.42%)
     
  • Crude Oil

    65.90
    +0.27 (+0.41%)
     
  • Gold

    1,792.00
    +7.70 (+0.43%)
     
  • Silver

    26.81
    +0.29 (+1.09%)
     
  • EUR/USD

    1.2031
    +0.0022 (+0.1805%)
     
  • 10-Yr Bond

    1.5840
    0.0000 (0.00%)
     
  • Vix

    18.51
    -0.97 (-4.98%)
     
  • GBP/USD

    1.3904
    -0.0003 (-0.0250%)
     
  • USD/JPY

    109.3100
    +0.1210 (+0.1108%)
     
  • BTC-USD

    56,978.47
    +2,098.67 (+3.82%)
     
  • CMC Crypto 200

    1,461.60
    +56.30 (+4.01%)
     
  • FTSE 100

    7,052.08
    +12.78 (+0.18%)
     
  • Nikkei 225

    29,331.37
    +518.74 (+1.80%)
     

UPDATE 2-EMA starts review of GSK's monoclonal antibody to treat COVID-19 patients

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
·2 min read
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.

(Adds GSK-Vir statement)

April 15 (Reuters) - The European Medicines Agency said on Thursday it is reviewing available data on the use of GlaxoSmithKline's monoclonal antibody to treat COVID-19 patients.

The agency said its review of VIR-7831, which GSK is developing with Vir Biotechnology Inc, will include data from a study comparing its effect with that of a placebo in patients with mild to moderate COVID-19 who were at high risk of progressing to a more severe condition. (https://bit.ly/3n0spGx)

While a more comprehensive rolling review is expected to start at a later time, the agency said the current review will provide European Union-wide recommendations for national authorities who may take decisions on early use of the medicine.

The companies reported in March that VIR-7831 reduced the risk of hospitalisation and deaths among patients by 85%, based on interim data from a study.

VIR-7831 has not been granted a marketing authorisation anywhere in the world. The companies said in a statement on Thursday they planned to submit a full marketing authorisation application to the EMA, and talks with global regulators were on to make VIR-7831 available to patients with COVID-19.

In late March, the companies filed an application to U.S. regulators for emergency use authorization of VIR-7831 to treat early-stage COVID-19 infections.

The United States has already recommended similar therapies from Eli Lilly and Co and Regeneron Pharmaceuticals Inc .

European health regulators are reviewing treatments from this class of medicines called monoclonal antibodies, which are synthetically manufactured copies of the human body's natural infection-fighting proteins and are already being used to treat some types of cancers.

GSK and Vir announced a partnership in 2020 to research COVID-19 treatments, and earlier this year said they will expand that partnership to develop monoclonal antibody treatments for influenza and other respiratory illnesses. (Reporting by Vishwadha Chander in Bengaluru; Editing by Bernard Orr and David Evans)