EMA Authorized 84 Drugs in 2018

January 4, 2019

In 2018, the agency authorized 42 drugs with new active substances, three advanced therapies, and 21 orphan drugs.

On January 4, 2019, the European Medicines Agency published its overview of authorizations of new medicines made in 2018. EMA gave positive opinions to 84 drugs in 2018 including 42 new active substances, 21 orphan drugs, and three advanced therapy products. More than 20 of the approved drugs were cancer treatments.

Advanced therapy medicine products (ATMPs) based on genes, cells, or tissues included included the first two chimeric antigen receptors (CAR) T-cell therapies (Kymriah and Yescarta) for treating blood cancers. The other ATMP, Luxturna, was approved to treat inherited retinal dystrophy caused by RPE65 gene mutations, which causes vision loss.

Pediatric medicines that were approved included Kigabeq, which treats infantile spasms (West’s syndrome) and resistant partial epilepsy; Slenyto, which treats insomnia in children and adolescents with autism spectrum disorder or Smith-Magenis syndrome; and Amglidia, which treats neonatal diabetes mellitus in newborns, infants, and children.

Treatments for rare diseases approved in 2018 included Lamzede, which treats mild to moderate forms of alpha-mannosidosis; Mepsevii, which treats mucopolysaccharidosis type VII; and Namuscla, which treats myotonia.

Source: EMA