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GemVax Secures Orphan Medicinal Product Designation in Europe, Following Approvals in the United States and Republic of Korea

GemVax & KAEL (082270, hereinafter GemVax) announced on May 29 that the European Medicines Agency (EMA) has granted Orphan Medicinal Product (OMP) designation to 'GV1001', the company’s investigational treatment for progressive supranuclear palsy (PSP).

This European regulatory milestone follows the recent receipt of both Orphan Drug Designation and Fast Track Designation from the United States Food and Drug Administration (FDA) earlier this month, establishing a comprehensive framework of regulatory support across major international markets.

GV1001 has now achieved Orphan Drug Designation status from all principal regulatory authorities governing new drug development, encompassing the United States, European Union and Republic of Korea.

EMA provides substantial incentives for the development of treatments targeting rare diseases affecting fewer than 50,000 patients within the European Union. These benefits encompass: ▲scientific advice and development support, ▲fee reductions or waivers for marketing authorization applications and scientific advice and ▲10 years of market exclusivity after commercialization.

GemVax previously secured significant advantages through FDA Orphan Drug Designation in the United States, including seven years of post-commercialization market exclusivity and tax credits of up to 25% of qualifying clinical development expenses. The additional FDA Fast Track Designation, granted on the May 7, is anticipated to further accelerate both clinical development timelines and the regulatory approval process for this PSP treatment.

Leveraging the comprehensive benefits and regulatory support derived from these Orphan Drug Designations and Fast Track status, GemVax intends to accelerate its global Phase 3 clinical trial program.

GemVax previously demonstrated favorable tolerability profiles and exhibited trends toward disease progression deceleration in Korea's inaugural Phase 2 clinical trial for PSP, which reached completion in the previous year. After the Korean Phase 2 clinical trial (having completed six months of dosing administration), a twelve-month extension study is currently progressing according to established timelines.

PSP is classified within the spectrum of atypical Parkinsonian syndromes, characterized primarily by 'supranuclear palsy' – the dysfunction of ocular movement resulting from abnormalities in brainstem nuclei. Additional clinical manifestations include gait disturbance, tremor, and cognitive deterioration similar to those observed in Parkinson's disease. However, PSP demonstrates a more rapid progression trajectory compared to Parkinson's disease and represents a neurodegenerative disorder for which no definitive therapeutic intervention currently exists.

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