EMA Says Yes To GSK’s Belantamab But Rejects Tagraxofusp & Emapalumab
GlaxoSmithKline's first-of-its kind treatment for multiple myeloma is among 11 new medicines that have won an EU approval nod from the European Medicines Agency this week.
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The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OKd new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.
US FDA-approved belantamab mafodotin is indicated for heavily pre-treated multiple myeloma and has a list price of $23,900 per month. Its REMS could limit initial uptake, but response rates have been encouraging.
Sales were down in the second quarter to $5.07bn, primarily due to coronavirus-related impacts, but Gilead’s COVID-19 antiviral therapy remdesivir will boost revenues in the second half.