Requests the Food and Drug Administration (FDA) to take the following actions to accelerate access to Pritelivir, an investigational treatment for Herpes Simplex Virus (HSV) patients. 1. Grant Expanded Access (Compassionate Use) to Pritelivir under the existing Expanded Access Programs (EAP) to allow patients with severe or refractory HSV infections access to the drug. | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

FDA-2024-P-5965

Requests the Food and Drug Administration (FDA) to take the following actions to accelerate access to Pritelivir, an investigational treatment for Herpes Simplex Virus (HSV) patients. 1. Grant Expanded Access (Compassionate Use) to Pritelivir under the existing Expanded Access Programs (EAP) to allow patients with severe or refractory HSV infections access to the drug.

Documents

Comments

855

Description

CLOSED

Key Dates

Comment Period OpensJan 2, 2025

Documents

Type	Title	Posted	Comments	Status
Other	Response Letter from FDA CDER to Herpes Heroes	May 11, 2026	--

Comment Statistics

Total Comments

855

Keywords

CDER

Citizen Petition

Herpes Heroes

Requests the FDA to take the following actions

to Pritelivir, an investigational treatment for

Herpes Simplex Virus (HSV) patients.

1. Grant Expanded Access (Compassionate Use) to

Pritelivir under the existing Expanded Access

Data from Regulations.gov