Zydus Cadila novel compound to treat malaria ZY-19489 gets Orphan Drug Designation from USFDA
Advertisement
Ahmedabad: Zydus Cadila, a research-driven, global healthcare provider, today announced that its antimalarial compound ZY19489 (MMV253), currently in development together with Medicines for Malaria Venture (MMV), a product development partnership (PDP) in antimalarial drug research, has received Orphan Drug Designation from the USFDA.
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 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.
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."
Read also: Zydus Cadila gets USFDA nod for Schizophrenia drug Cariprazine
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.