EMA will request more data on Raxone, delaying bid for label expansion
Santhera Pharmaceuticals (SIX: SANN) says its bid to broaden the European label of Raxone (idebenone) has been delayed.
The Swiss drugmaker has applied to extend the marketable use of the drug, to include slowing loss of respiratory function in patients with Duchenne muscular dystrophy (DMD) who are currently not taking glucocorticoids.
Santhera says it is “now expecting to receive a request for supplementary information to further support the clinical relevance of our data,” and anticipates a decision in the third quarter of this year.
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