Neupharma announces the new designation recently obtained from the US Food and Drug Administration.
In the years 2017 and 2018, Teicoplanin in inhaled formulation against methicillin-resistant Staphylococcus Aureus (MRSA) infections in patients with Cystic Fibrosis has obtained Orphan Drug designations by the FDA and EMA.
In September 2020, the drug was recognized as a Pediatric Orphan drug for the treatment of Staphylococcal Aureus infections in pediatric patients with Cystic Fibrosis by the FDA.
The development of the drug is in progress: the phase 1 clinical study is at its end. The study has been conducted at the Clinical Research Center "Borgo Roma” Hospital in Verona.
For Neupharma, the conclusion of this study is an important milestone in the development of the Cystic Fibrosis R&D portfolio.
EP & CP