EMA Recommends New Measures For JAK Inhibitors After Confirming Serious Risks
The sponsors of five EU-approved Janus kinase inhibitors for inflammatory conditions will have to update their product information to reflect new measures and warnings from the European Medicines Agency.
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New chief financial officer Thad Huston said that Galapagos was evaluating “various strategic options for Jyseleca,” the company’s only revenue source, given that the landscape for the JAK class in Europe “has changed significantly over the past six months.”
The Barcelona-based group is confident that Lilly-partnered lebrikizumab has the potential to become a best-in-class treatment for atopic dermatitis and take market share from Sanofi’s blockbuster Dupixent.
The European Medicines Agency has been asked to make a recommendation by 30 September on whether the marketing authorization for the products concerned should be maintained, varied, suspended or revoked.