THE EUROPEAN MEDICINES AGENCY RECOMMENDS AUTHORISATION OF NEOATRICON® A NEW PAEDIATRIC FORMULATION FOR TREATMENT OF HYPOTENSION IN NEONATES, INFANTS AND CHILDREN
Chief Executive Officer at BCO Pharma
Irish owned BrePco Biopharma Limited (BPCO) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on 21 March 2024 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 commercialization 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.
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About BrePco Biopharma Limited: Ireland-based BPCO develops products for the unique needs of paediatric patients. The development of Neoatricon® was part funded by the European Commission within the 7th Framework Programme (“FP7”). www.bcopharma.com
About Piramal Critical Care: Piramal Critical Care (PCC), a division of Piramal Pharma Limited, is a global leader in anaesthesia, pain management, intrathecal therapy, and critical care medicine. PCC products are available in more than 100 countries, including the US and the European markets. Piramal Critical Care has a focus on improving outcomes for patients with high quality products manufactured in-house or in partnership with leading pharmaceutical development and manufacturing organizations around the world. For more information and updates, please visit: www.piramalcriticalcare.com