Island Pharmaceuticals (ASX:ILA) has confirmed that the US Food and Drug Administration will provide formal feedback on its antiviral candidate Galidesivir by 12 November 202, despite recent government shutdowns in the United States.
The company is seeking regulatory alignment on using the FDA’s Animal Rule pathway to fast-track Galidesivir’s approval for the treatment of Marburg virus disease. The company said the pending feedback is expected to clarify key elements of the development program, including the design of upcoming non-human primate studies and the potential eligibility of Galidesivir for a Priority Review Voucher (PRV).
The correspondence follows the granting of a Type C meeting request in September, enabling Island to formally engage with the FDA on a development and approval pathway for the antiviral. To support the review, Island has submitted a comprehensive briefing package that includes pharmacokinetic and safety data, animal study results and supporting documentation for the proposed regulatory approach.
In parallel with the regulatory process, the company is advancing negotiations with strategic partners to initiate its planned Marburg animal study. Galidesivir is a clinical-stage broad-spectrum antiviral with activity against more than 20 RNA viruses, including Ebola, MERS, Zika and yellow fever.
Island CEO and Managing Director Dr David Foster said the FDA’s commitment to the 12 November deadline reflects the significance of the program. “Receiving confirmation from the FDA that written feedback remains on schedule – despite the backdrop of US government shutdowns – is a very positive development for Island and highlights Galidesivir’s potential public health importance,” he said.
“Maintaining this level of engagement with the FDA during a period of widespread operational disruption reflects the strength of our communication with the Agency and the seriousness with which Galidesivir’s development and potential approval pathway is being treated. We look forward to receiving the FDA’s formal written guidance next month as we continue to progress both regulatory and operational milestones in parallel,” Foster added.