FDA Grants Island Type C Meeting to Advance Galidesivir Approval by November
Island Pharmaceuticals has won a crucial FDA Type C meeting to discuss fast-tracking its antiviral Galidesivir for Marburg virus treatment, with written feedback expected by November.
- FDA grants Type C meeting under Galidesivir’s open IND application
- Opportunity to align on Animal Rule use for accelerated approval
- Clarification sought on animal study design and Priority Review Voucher eligibility
- Written FDA feedback expected by 12 November 2025
- Animal study negotiations progressing on schedule
Regulatory Milestone for Galidesivir
Australian antiviral developer Island Pharmaceuticals (ASX, ILA) has achieved a significant regulatory step with the US Food & Drug Administration (FDA) granting a Type C meeting request under its open Investigational New Drug (IND) application for Galidesivir. This meeting, scheduled to culminate in written feedback by mid-November, offers Island a valuable opportunity to clarify the pathway for fast-tracking Galidesivir’s approval for treating the deadly Marburg virus.
Leveraging the FDA’s Animal Rule
Central to Island’s strategy is the FDA’s Animal Rule, a regulatory pathway that allows drug approval based on animal efficacy data when human trials are not feasible or ethical, particularly relevant for rare but high-risk viral infections like Marburg. The upcoming FDA feedback will address how Island can best utilize this rule, potentially accelerating Galidesivir’s availability for urgent public health needs.
Clarifying Study Design and Incentives
Island will also seek guidance on the design of its pending animal studies, which are critical to demonstrating Galidesivir’s efficacy under the Animal Rule. Additionally, the company aims to confirm whether Galidesivir qualifies for a Priority Review Voucher (PRV), a valuable regulatory incentive that can expedite future drug reviews or be sold to other companies.
Progress on Animal Studies and Next Steps
Negotiations with study partners are advancing well, with plans to commence and complete the animal study in the next quarter. Island plans to submit a comprehensive briefing package to the FDA in the coming weeks, compiling all relevant historical data to support the discussions. CEO Dr David Foster highlighted the importance of this milestone in advancing Galidesivir towards approval and reinforcing Island’s role in addressing high-priority viral threats.
Strategic Implications
This FDA engagement underscores Island’s commitment to becoming a trusted supplier for government stockpiles against biosecurity threats. Success here could position Galidesivir as a critical antiviral for Marburg and other RNA viruses, potentially opening doors to broader applications and partnerships in global health security.
Bottom Line?
Island’s FDA dialogue could unlock a faster path to market for Galidesivir, but the final regulatory verdict and animal study outcomes remain pivotal.
Questions in the middle?
- Will the FDA’s written feedback fully endorse the use of the Animal Rule for Galidesivir?
- How might Priority Review Voucher eligibility impact Island’s commercial strategy?
- What are the potential timelines and risks associated with the upcoming animal study?
