Journey Medical (DERM) FDA Announcement summary

Introduction and purpose

• FDA approved Emrosi (DFD-29/Minocycline Hydrochloride Extended Release Capsules, 40 mg), a novel oral treatment for inflammatory papulopustular rosacea in adults, developed in collaboration with Dr. Reddy's Laboratories, marking a significant milestone for the dermatology field.

• Emrosi is a modified minocycline 40 mg capsule with immediate and extended-release properties, designed to address unmet needs and provide a new oral standard of care for millions of U.S. rosacea patients.

Details of approval or decision

• FDA approved Emrosi with a differentiated label, no special post-marketing commitments, and on-time approval, adopting the Emrosi brand name.

• Approval is based on two Phase 3 clinical trials that met all co-primary and secondary endpoints, showing statistically significant superiority over Oracea 40 mg capsules and placebo.

• Emrosi is the first new oral rosacea treatment since 2006.

• Journey Medical will commercialize Emrosi in the U.S. with its dermatology-focused sales force.

Impact on industry and stakeholders

• Emrosi is expected to benefit an estimated 16 million rosacea patients in the US and provide practitioners with a new, superior oral option.

• Rosacea affects over 16 million Americans and 415 million people worldwide, with significant impacts on quality of life.

• Market research indicates about 70% of dermatology practitioners would prescribe Emrosi, and payers covering over 200 million lives are likely to contract for coverage.

• The success of Emrosi is critical to Journey Medical's business and future revenue.