The European Medicines Agency’s advisory committee CHMP has confirmed its negative opinion issued in June against approving Novartis’ (NVS -0.5%)
Revolade (eltrombopag) as add-on treatment in previously untreated
patients at least 12 years old with severe aplastic anemia who are not
candidates for autologous stem cell transplant.
CHMP stated that the clinical study supporting the
application was inadequate to show a treatment effect in these patients
since there was no direct comparison between Revolade +
immunosuppressive therapy and immunosuppressive therapy alone.
Revolade is currently approved in the EU for
adults with severe aplastic anemia, patients at least one year old with
primary immune thrombocytopenia and HCV-positive adults with
thrombocytopenia.
https://seekingalpha.com/news/3506932-novartis-strikes-expanded-use-eltrombopag-europe
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