Expanded Access Policy
Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under Section 561(b) of the Federal Food, Drug and Cosmetic Act (FD&C Act) for provision of such a drug. The following is Antiva’s policy for evaluating and responding to requests for individual patient access to investigational drugs that are intended to treat serious diseases.
Antiva believes that investigational drugs should be studied in patients within clinical trials designed to obtain safety and efficacy data intended to support product approval and subsequent wider patient accessibility. We encourage patients to speak with their physicians and to participate in clinical trials. In rare instances when patients with serious diseases have exhausted all available therapies and may benefit from treatment with
Contact Information: A treating physician, currently licensed in the United States, may submit questions or requests regarding expanded access to the following:
Request Procedure: Requests should be submitted by the treating physician and should include sufficient supporting detail to enable Antiva to evaluate the expanded access request. Please include contact information so Antiva can follow-up with the treating physician directly (i.e., address, phone number, email address). Requests for expanded access need to be made by the physician responsible for treating the patient, and each request needs to relate to a single patient.
Antiva does not require patients nor requesting physicians to pay for the cost of investigational products. Antiva is not responsible for the cost of patient care under the study protocol, unless a written agreement is in place for Antiva to reimburse or cover any specific costs associated with the use of Antiva’s investigational product in this setting.
General Criteria: At this time, Antiva can only consider expanded access requests under the following circumstances:
- from physicians from well-established medical institutions in the United States
- for indications/conditions that include:
- HPV-associated high-grade precancerous lesions, other than cervical intraepithelial neoplasia (CIN), anal intraepithelial neoplasia (AIN) or peri-anal intraepithelial neoplasia (PAIN)
Antiva will evaluate and respond to each expanded access request that it receives on a case-by-case basis. Antiva will provide investigational drug necessary to support single-person expanded access only if such provision does not hinder Antiva’s ongoing clinical trials.
Since ABI-1968 is at an early stage of development, and before safety and efficacy have been established in the high-grade CIN and AIN indications, Antiva will only offer investigational products to patients with those indications through participation in controlled clinical studies. We encourage participation in a clinical study as this will enable Antiva to progress development to a stage where the product will be available to a broader population. Please check the Products section of our website and www.clinicaltrials.gov for ongoing clinical studies.
- Anticipated Timing: Antiva anticipates that it will acknowledge receipt of any expanded access questions or requests within 30 calendar days of receipt.
- Clinical Trials: This website and policy will be updated with a hyperlink or other reference to the expanded access record on www.clinicaltrials.gov if and when such record becomes active.
As authorized by the 21st Century Cures Act, Antiva may revise this expanded access policy at any time. Additionally, the posting of this policy by Antiva shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
POL001 (1.0) Version Date: 23 May 2018