The sponsors of 17 products that are in the late stages of evaluation by the European Medicines Agency will this week be discovering what outstanding questions the agency has regarding their marketing authorization applications (MAAs).
Among the products are six orphan therapies for rare or ultra-rare diseases, including Akcea Therapeutics’s volanesorsen for familial chylomicronemia syndrome (FCS), Ionis USA’s inotersen for the treatment of transthyretin amyloidosis (hATTR), and