EMA Wants Drugmakers to Perform Pediatric Tests Prior to Approval

The European Medicines Agency is declaring that six classes of diseases occur in children, forcing drugmakers to conduct pediatric tests prior to approval.

Officials expect this to increase the availability of drug treatments for children, pointing out that of 26 anticancer drugs approved for adults between 2012 and 2014, only 14 had a development plan for use by pediatric patients.

The EMA is revoking class waivers for liver and intrahepatic bile duct carcinoma; kidney and renal pelvis carcinoma; coronary atherosclerosis, peripheral atherosclerosis, vascular dementia and vascular cognitive disorder; Parkinson’s disease; Huntington chorea; and amyotrophic lateral sclerosis.

The agency is revising 15 class waivers to note that the drugs are ineffective in children. The classes affected include first-generation taxoid drugs, ecteinascidin drugs, thymidylate synthase inhibitor drugs, immunomodulatory cytokine drugs, photosensitizing drugs and androgen antagonists.

The update takes effect in 2018. Read the EMA’s decision at www.fdanews.com/7-15-EMA-ClassWaivers.pdf and a Q&A here: www.fdanews.com/7-15-EMA-QA.pdf. — Jonathon Shacat