The European Medicines Agency’s drug evaluation committee, the CHMP, recommended 84 new medicines for EU approval in 2018, down from 92 in 2017. They included products containing a total of 42 new active substances, compared with 35 NAS in the previous year.
Among the drugs given a positive opinion by the CHMP were three advanced therapy medicines – Novartis AG’s Kymriah (tisagenlecleucel) and Gilead Sciences Inc.’s Yescarta (axicabtagene ciloleucel) for blood cancers, and Spark Therapeutics Inc.’s Luxturna (voretigene neparvovec) for inherited retinal dystrophy