BrePco Biopharma (BPCO) and Piramal Critical Care (PCC) has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a grant of a Marketing Authorisation for the use of Neoatricon - the first paediatric strength solution for infusion of Dopamine Hydrochloride.
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PCC has secured the commercialisation rights for the EU, UK, and Norway and will be responsible for distributing Neoatricon in these regions.
Developed by BPCO, Neoatricon is an age-appropriate, ready-to-use, sterile solution for infusion of Dopamine Hydrochloride. It is available in a concentration of 1.5mg/mL in a 30 mL vial and a higher strength containing 4.5mg/mL in a 50 mL vial.
Paul Breen, director of BPCO said: “The approval of this new paediatric formulation represents a much-needed opportunity to improve the outcomes for these vulnerable patients by improved safety – ensures accurate dosing, reducing the risk of under or overdosing compared to diluting or adjusting adult formulations. It makes it easier for healthcare providers to administer in emergency settings. It minimises preparation time in neonatal and paediatric intensive care units (NICU & PICU), allowing for quicker intervention.”
Currently, there are no approved Dopamine Hydrochloride formulations specifically indicated for use in neonates, infants, or children, with off-label use remaining a common practice. The approval of Neoatricon addresses this critical gap by ensuring precise dosing, reducing the risk of under- or overdosing, and minimising preparation time in neonatal and paediatric intensive care units (NICU & PICU), facilitating faster intervention in emergency settings.
Peter DeYoung, CEO, Piramal Global Pharma said: “We are thrilled to announce the approval of Neoatricon, the first and only authorised treatment for hypotension in neonates, infants, and children. This milestone marks an important step for Piramal Critical Care as we expand into a new therapeutic area. Our partnership with BrePco Biopharma has allowed us to bring forward an innovation that will significantly improve health outcomes for paediatric patients.”