Zydus receives Orphan Drug Designation from US FDA for malaria treatment
The Orphan Drug Designation provides up to seven years of marketing exclusivity in the US
Zydus Cadila today received Orphan Drug Designation from the US Food and Drug Administration (FDA) for its antimalarial compound ZY19489 (MMV253), currently in development together with Medicines for Malaria Venture (MMV), a leading product development partnership (PDP) in antimalarial drug research, the company notified via a statement.
The statement said that the orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.
The phase-I study of ZY19489 has demonstrated a long half-life and potential for a single-dose cure for malaria. In a separate malaria challenge trial, potent antimalarial activity has been demonstrated following single-dose oral administration of ZY19489, the statement mentioned.
Speaking on the development, Pankaj R Patel, Chairman, Zydus Group, said, “As a global community facing threats from rapidly mutating malaria strains and the rise in artemisinin resistance cases, we have to be prepared with novel therapeutic drugs. ZY-19489 is a potential single-dose radical cure for P. falciparum and P. vivax malaria which is a major global health risk today.”
“ZY19489 is a potent, first-in-class molecule, originally discovered and elaborated in India,” said Dr Timothy Wells, Chief Scientific Officer, MMV.
He added, “The drug has tremendous potential as part of a new generation of treatments and is fully active against drug-resistant strains of malaria which are increasingly a concern.”