IMMEDIATE RELEASE Herpes Heroes is urging the public to participate in a pivotal public comment period concerning the FDA’s review of a Citizen Petition advocating for expanded access, accelerated approval, and priority review for Pritelivir, a promising treatment for Herpes Simplex Virus (HSV). This petition aims to address the urgent needs of millions of Americans suffering from severe, drug-resistant, or recurrent HSV infections. Herpes Heroes makes no assurances with the final outcome of this petition because the final decision is up to the agency but we believe that this can move along HSV policy.
Pritelivir: A Potential Game-Changer in HSV Treatment
Pritelivir represents a groundbreaking antiviral therapy that could significantly improve the lives of those affected by HSV, particularly patients with few or no effective treatment options. Current antiviral treatments are increasingly ineffective for drug-resistant strains, leaving many people living with HSV to endure painful symptoms and severe complications without relief.
Key Points from the Petition:
Expanded Access (Compassionate Use): The petition requests the FDA to grant expanded access to Pritelivir for patients with severe or refractory HSV infections. This would allow those with limited treatment options to benefit from this promising therapy.
Accelerated Approval: Pritelivir has shown significant efficacy in clinical trials, particularly for drug-resistant strains of HSV. The petition urges the FDA to consider accelerated approval using surrogate endpoints such as viral load reduction.
Priority Review: Recognizing the unmet medical need and the disproportionate impact on vulnerable populations, the petition calls for a priority review designation to expedite the approval process and make Pritelivir available sooner.
Public Health and Economic Impact: The petition highlights the potential for Pritelivir to reduce healthcare costs, improve mental health outcomes, and provide better treatment options for underserved communities, including minorities, low-income individuals, and pregnant women.
Your Voice Matters: The Power of Public Comments
Why submit a comment? Public comments are a critical component of the regulatory process, allowing individuals to express their support and share personal experiences with the FDA. By contributing your voice, you can:
Amplify the Urgency: Highlight the critical need for new treatment options like Pritelivir, emphasizing the widespread impact of HSV on public health.
Support the Underserved: Advocate for those disproportionately affected by HSV, including minority communities, low-income individuals, pregnant women, and the immunocompromised.
Influence Policy Decisions: Show the FDA that there is strong public backing for swift regulatory action, potentially accelerating the approval process and expanding access to Pritelivir.
How to Submit Your Comment
Herpes Heroes encourages everyone affected by HSV or concerned about public health to submit their comments to the FDA. We need to hear from healthcare providers, patients, academics, etc. Encourage your doctors to send in a comment. This is an opportunity to make a tangible difference in the lives of millions.
To help make your comment effective, follow these simple tips:
Be Concise but Clear: Clearly state your position and support it with personal experiences, data, or scientific evidence.
Focus on Key Issues: You don’t need to address every issue in the petition. Select the ones that matter most to you.
Provide Constructive Feedback: Whether you agree or disagree, offer suggestions and alternatives if possible.
Include Specific Details: Reference specific points or sections in the petition if relevant.
Highlight Personal Impact: Explain how lack of access to updated medication affects you or your community.
WE RECOMMEND WRITING IN YOUR OWN WORDS. WHEN USING AI TO GENERATE COMMENTS PLEASE GO BACK IN THE TEXT AND REVISE TO ADD MORE PERSONAL TOUCHES SO THAT IT DOES NOT GET MARKED AS SPAM
Click this link to write a comment: https://www.regulations.gov/commenton/FDA-2024-P-5965-0001
To read the petition click:
https://www.regulations.gov/document/FDA-2024-P-5965-0001
Headline suggestions
Every Second A New Person Acquires Genital Herpes – Why Hasn’t the FDA Intervened
Outdated drugs and few solutions for patients, why is the FDA gatekeeping this promising antiviral medication
Genital Herpes is on the Rise and Hurting Marginalized Communities in the Process
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