Zydus gets orphan drug designation from USFDA for antimalarial compound

Zydus Cadila said its antimalarial compound ZY19489′, which is currently under development with Medicines for Malaria Venture (MMV), has received ‘orphan drug designation’ from the US FDA.

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 USFDA approval. Medicines for Malaria Venture (MMV) is a leading product development partnership in antimalarial drug research.

The ZY19489 is a novel antimalarial compound active against all current clinical strains of malaria-causing microorganisms ‘P. falciparum’ and ‘P. vivax’, including drug-resistant strains. In the phase-I study, the compound has demonstrated a long half-life and potential for a single-dose cure for malaria. It has also demonstrated potent anti-malarial activity following single-dose oral administration in a separate malaria challenge trial.