BrePco Biopharma, in partnership with Piramal Critical Care, has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Neoatricon.

This marks the approval of the first paediatric-strength solution for infusion of Dopamine Hydrochloride specifically formulated for neonates, infants, and children.

Neoatricon, developed by BrePco Biopharma, is an age-appropriate, ready-to-use, sterile solution available in two concentrations: 1.5 mg/mL in a 30 mL vial and a higher strength of 4.5 mg/mL in a 50 mL vial. Piramal Critical Care has secured exclusive commercialisation rights for Neoatricon across the European Union, the United Kingdom, and Norway, and will oversee its distribution in these regions.

Until now, there have been no authorised Dopamine Hydrochloride formulations explicitly indicated for paediatric use, with off-label administration of adult formulations being common in neonatal and paediatric intensive care units. The approval of Neoatricon directly addresses this gap by enabling precise dosing, reducing the risk of underdosing or overdosing, and significantly cutting down preparation time in emergency scenarios. This ensures more efficient cardiovascular intervention during critical care situations in NICU and PICU settings.

Paul Breen, Director of BrePco Biopharma, stated that this approval represents a major opportunity to enhance safety and outcomes for vulnerable paediatric patients. He emphasised that the ready-to-use formula improves dose accuracy and simplifies administration during emergencies, which is critical in intensive care environments.

Peter DeYoung, CEO of Piramal Global Pharma, expressed pride in the milestone, noting that Neoatricon is the first and only authorised treatment for hypotension in neonates, infants, and children. He added that this approval signifies Piramal’s strategic entry into a new therapeutic area and highlighted the company’s commitment to advancing health outcomes for paediatric patients through innovation.

Neoatricon 1.5 mg/mL is intended for use in neonates, including those of extremely low gestational age, as well as in infants and children weighing under 10 kg who require cardiovascular support. The 4.5 mg/mL variant is suitable for infants and children weighing 10 kg or more, including adolescents, and is designed for the same purpose.

Neoatricon’s development was partially funded by the European Commission under the 7th Framework Programme. With this regulatory approval, Neoatricon establishes a new benchmark in paediatric critical care and represents a meaningful advancement in tailored pharmaceutical care for children.