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BrePco Biopharma (BPCO) have announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the granting of a paediatric use marketing authorisation (PUMA) for the use of Neoatricon intended for the treatment of hypotension in neonates, infants and children under 18 years of age.
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to issue a Marketing Authorisation for medicines to be supplied in the European Union (EU).
Piramal Critical Care (PCC), a global leader in critical care medicines have acquired the EU, UK and Norway commercialisation rights and will distribute Neoatricon in those countries.
Developed by BPCO, Neoatricon is an age-appropriate, ready-to-use, sterile solution for infusion of Dopamine Hydrochloride. Neoatricon is easier to use than current adult formulations and its use will reduce delays and potential errors in the process of administering this drug to babies and children. It will be 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 noted that “it is of significance that Neoatricon will be approved for use in infants and children. The approval of this new paediatric formulation represents a much-needed opportunity to improve the outcomes for these vulnerable patients”
Dopamine hydrochloride is an important drug for the estimated 130,000 paediatric patients, mostly new-born babies and infants, that are treated for hypotension in Europe each year. The conditions associated with hypotension are often life-threatening and require urgent intervention. Currently there are no dopamine hydrochloride formulations approved for use in neonates, infants, or children, nor is it supplied in a dosage form suitable for paediatric patients. The use of off-label medications in children remains a common practice.
Dopamine hydrochloride has been listed on the World Health Organization List of Essential Medicines for Children. Dopamine HCl was granted an Orphan Designation for the prevention of non-traumatic intraventricular haemorrhage (IVH) in premature neonates by the US Food and Drug Administration.