EU Ultomiris Approval Rounds Off A Good Week For Alexion’s Complement Franchise
A first EU approval for Ultomiris added to a label expansion for Soliris in the US made for a good seven days for Alexion’s C5 product portfolio.
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Keeping Track: US FDA Closes Out First Half Of 2019 With CRL For Edsivo, But A Burst Of Supplemental Approvals
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A total of 13 new drugs have been recommended for pan-EU approval, while one has failed to meet the European Medicines Agency’s standards.
Positive late-stage clinical results involving Ultomiris in a second potential indication suggest Alexion is on the right track to develop new ultra-rare disease therapies with significant commercial potential.