EMA recommends Cystadrops (mercaptamine) for Infants with Cystinosis-Recordati

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Cystadrops. The marketing authorisation holdert is Recordati Rare Diseases. The CHMP adopted an extension to the existing indication to include treatment of children from 6 months of age, as follows: Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 6 months  of age with cystinosis. Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission. This decision marks a significant advancement in managing cystinosis, particularly in children as young as six months. This extension addresses a critical need for early intervention in managing the disease’s ocular manifestations.