EVE Health Group has secured regulatory approval enabling prescription access for its lead products Libbo and Dyspro in Australia, setting the stage for a commercial rollout before the end of 2025.
- Regulatory approval achieved for Libbo (ED) and Dyspro (dysmenorrhoea) under TGA pathways
- First commercial batch purchase order for Dyspro submitted
- National prescriber coverage established via telehealth and GP clinics
- Commercial launch in Australia targeted before end of 2025
- Plans underway for full Australian registration and export market expansion
Regulatory Milestone Unlocks Market Entry
EVE Health Group (ASX – EVE) has announced a significant regulatory achievement, confirming that it has met all necessary requirements to enable prescription access to its flagship products, Libbo and Dyspro, in Australia. This clearance under the Therapeutic Goods Administration (TGA) medicines access pathways paves the way for the company’s commercial launch within the calendar year 2025, ahead of its original timeline.
Innovative Products Targeting Unmet Needs
Libbo, an oral soluble film containing tadalafil, addresses erectile dysfunction (ED), while Dyspro, a cannabinoid-based pastille, targets dysmenorrhoea, a common and often under-treated menstrual pain condition. Both products leverage fast-acting oral dissolvable formats, designed to improve patient convenience and compliance. The company’s commitment to pharmaceutical good manufacturing practices (GMP) is reflected in stability data supporting expiry periods of two years for Libbo and one year for Dyspro.
Commercial Readiness and Distribution
With regulatory hurdles cleared, EVE is focusing on operational preparations including finalising manufacturing and packaging, appointing a national distribution partner, and integrating prescribing and dispensing software. The company has already submitted its first commercial batch purchase order for Dyspro and secured national prescriber coverage through telehealth and general practitioner clinics, ensuring broad patient access upon launch.
Looking Beyond Australia
Following the initial market entry, EVE plans to apply for full registration on the Australian Register of Therapeutic Goods (ARTG), a move that will facilitate international expansion. Export submissions are in preparation to support global market ambitions, positioning EVE to capitalize on unmet needs in men’s and women’s health beyond domestic borders.
Leadership Perspective
Ben Rohr, EVE’s Chief Operating Officer, highlighted the significance of this milestone, emphasizing the company’s strategic focus and dedication to delivering innovative, fast-acting health solutions. This regulatory clearance not only validates EVE’s development and regulatory approach but also sets a clear path toward commercialisation and growth.
Bottom Line?
EVE’s regulatory breakthrough sets the stage for a pivotal commercial launch, with market impact and international ambitions now in sharper focus.
Questions in the middle?
- What are the expected sales volumes and revenue forecasts for Libbo and Dyspro post-launch?
- How will EVE’s products compete with existing treatments in the Australian men’s and women’s health markets?
- What is the timeline and likelihood for securing full ARTG registration and successful export approvals?