Helsinn And AB Science Persevere In EU Despite CHMP Setback
Helsinn and AB Science plan to conduct additional studies with their products the CHMP turned down this month, in an effort to secure eventual EU approval in the rejected indications. A third company, XBiotech, hasn’t ruled out similar action. New MAAs would be required.
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Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will likely shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.
Where now for XBiotech? The US firm says that despite a big setback for Xilonix in the EU, it will continue to develop the product in oncology.
Fourteen medicines that are in the final stages of the evaluation process at the European Medicines Agency should find out this week whether they will be approved for marketing across the EU.