Treatment For Maple Syrup Urine Disease Among 10 New EU Filings

REC 0545, for MSUD, and aztreonam-avibactam, for serious Gram-negative bacterial infections, are among the latest drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.

The EU regulator has started reviewing marketing applications for a new batch of medicines • Source: Shutterstock

REC 0545, Recordati’s investigational treatment for maple syrup urine disease (MSUD), a rare genetic metabolic disorder that starts in early infancy, is among the latest products that the European Medicines Agency has begun reviewing for potential pan-EU marketing authorization.

MSUD, which gets its name from the distinctive sweet odor of urine in infants with the condition, is a disease in which the body is unable to properly process certain amino acids. The condition is characterized by lack of appetite, vomiting, lethargy, seizures, abnormal movements and developmental delay

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