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HomeNews UpdateApproval sought for two paediatric antibiotics for MDR infections

Approval sought for two paediatric antibiotics for MDR infections

US pharmaceutical company Melinta Therapeutics is to receive funding from the government’s Biomedical Advanced Research and Development Authority (BARDA) to advance two antibiotics targeting multidrug-resistant infections in children.

Baxdela (delafloxacin) and Vabomere (meropenem and vaborbactam) are already approved by the US Food and Drug Administration (FDA) for use in adults, reports CIDRAP.

Baxdela is used to treat acute bacterial skin and skin-structure infections and community-acquired bacterial pneumonia (CABP), and Vabomere is designed for gram-negative pathogens that produce beta-lactamase enzymes.

The $20.5m base funding from BARDA will support plans to extend Baxdela’s CABP indication to children aged between two months to under 18 years and Vabomere’s use for complicated urinary tract infections to children aged from three months to under 18.

Melinta will also use the funding to seek approval for using Vabomere to treat late-onset neonatal sepsis in infants younger than three months and for Baxdela as a potential treatment option against biothreat pathogens in children and adults.

The company will submit four supplemental New Drug Applications to the FDA for these new indications. Under the contract, Melinta could receive an additional $121.4m from BARDA if all options are exercised.

 

CIDRAP article – Melinta to seek approval of 2 antibiotics for use in kids, against biothreats (Open access)

 

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