First Oral Treatment For Spinal Muscular Atrophy Gets EMA Nod
Two Of Six Drugs Recommended For EU-Wide Use Have Orphan Designation
New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.
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The firm has stumped up $60m for Ionis’s preclinical antisense asset in spinal muscular atrophy, a potential successor to the slowing Spinraza, which also faces patent expiry in a few years.
The UK has pipped the EU to the post in granting a marketing authorization to what the health secretary describes as “a significant addition to our armoury to tackle COVID-19.”
Novartis is trying its luck with capmatinib on the accelerated assessment front at the European Medicines Agency. Gilead and Astellas/Seagen have secured fast-track review for their respective potential new products while Sesen Bio and Amryt Pharma are dealing with rejection.