XBiotech Says CHMP ‘No’ Was A Surprise, Despite The Signs
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.
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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.
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.
Texas-based biotech XBiotech is going to find it tough to persuade clinicians and regulators about the usefulness of it its human antibody Xilonix after it discontinued the second Phase III study of the human antibody, in US colorectal cancer patients.