BMS’ Plaque Psoriasis Drug Deucravacitinib Among Six Hopefuls Awaiting EMA Verdict
A novel TYK2 inhibitor and a drug to treat an ultra-rare genetic disorder are among products up for a marketing authorization opinion this week from the European Medicines Agency’s human medicines committee, the CHMP.
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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.
Four of the six products up for a marketing authorization opinion from the EMA’s advisory committee, the CHMP, this week are orphan drugs. One of them, omburtamab, was recently turned down by a US FDA advisory panel.
Panel to review overall survival data on GSK’s Zejula for ovarian cancer ‘is no longer needed,’ US FDA says. Meeting to consider pediatric indication for Viatris’ Revatio was also cancelled though sNDA remains active. FDA to review new information on Ipsen’s palovarotene clinical trial data.