Piramal Pharma arm gets approval to market paediatric infusion Neoatricon in UK; check details

Piramal Pharma on Thursday, March 20, said that BrePco Biopharma Limited (BPCO) and Piramal Critical Care (PCC) division has received marketing authorisation from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the sale of Neoatricon in the UK.

Piramal in a statement to the stock exchanges explained that Neoatricon is a new first-ever paediatric (i.e. for children) Dopamine Hydrochloride formulation, developed by BPCO, for the treatment of hypotension or abnormally low blood pressure in newborns, infants and children.

Piramal Critical Care (PCC), a division of Piramal Pharma, has secured the commercialisation rights of Neoatricon in the European Union, United Kingdom and Norway, and will be responsible for its distribution in these regions.

Neoatricon will be available for purchase in the pharmacies 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 in the EU, UK and Norway.

“We are thrilled to announce the approval of Neoatricon. 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,” Peter DeYoung, CEO of Piramal Global Pharma remarked.

As per the company, the 1.5 mg/mL concentration is most suitable for newborns, including those of extremely low gestational age, infants and children below 10 kg body weight. The Neoatricon 4.5mg/ml is the most suitable for infants and children weighing 10 kg or above and adolescents.

The off-label use of Dopamine Hydrochloride formulations in newborns, infants and children has been a common practice as there were no approved formulations before this.

The approval of Neoatricon will ensure precise dosing, reduce the risk of under or over-dosing and minimise the “preparation time in neonatal and paediatric intensive care units (NICU & PICU), facilitating faster intervention in emergency settings,” Piramal added.

Commenting on the approval,BPCO director Paul Breen, 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 minimizes preparation time in neonatal and paediatric intensive care units (NICU & PICU), allowing for quicker intervention.”

Shares of Piramal Pharma closed in the green at ₹221.29 apiece, up 1.28% on the National Stock Exchange (NSE) on Thursday. However, the approval was announced after market hours.