Company Directory

Single-Patient EA Policies/Criteria

We ask that the physician in charge of the patient ask for Pre-approval access to investigational drug. Each request will be reviewed by a physician to assure that the eligible patients can receive pre-approval investigational drug.

Decisions for Pre-Approval Access to the investigational medicine will be based on the safe use in the patient, given the investigational nature of these medicines that have not completed clinical trials for the specific disease and state. Next is the likelihood of benefit for the patient based on the clinical results of the investigational medicine. Discussion with the physician managing the patient will help determine if the investigational agent is the best option for the patient. Decisions for drug access will be made in a fair and equitable process. There is no guarantee that each request will be fulfilled.

We must also ensure that by providing the drug outside the clinical trial the completion of the trial, and thus drug development plan, regulatory review and approval is not adversely affected.

Request for Pre-Approval Access must be made by your physician who will request the drug from VasGene Therapeutics, Inc. VasGene will respond to the request within 5 business days.

Below are the Eligibility Criteria for the request:

· The illness must be serious or life threatening.

· There are no other viable options (including approved products or active clinical trials).

· There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks based on
what is known at present.

· There is a plan in place to make the medicine, once approved, available commercially.

· Whether or not sufficient quantities of the investigational medicine are available.

· Additional regarding the therapy, its development program, the patient, or other circumstances may impact eligibility.

Available Therapies via Single-Patient EA

sEphB4-HSA

Single-Patient EA Policies/Criteria

Vaxxinity is committed to developing safe and effective immunotherapeutic vaccines, with a goal of providing our next generation products as soon as possible through efficient product development. At this time, Vaxxinity’s investigational products can only be accessed through participation in a clinical trial. Vaxxinity does not currently offer an expanded access program.

Available Therapies via Single-Patient EA

Currently, Vaxxinity has no products available via single-patient EA.

Single-Patient EA Policies/Criteria

At present, Vedanta has not established an expanded access program and does not offer expanded access to our investigational product candidates outside of a clinical trial.

Disease/Category-Specific EA Policies/Criteria

https://www.vedantabio.com/clinical-trials/expanded-access

Single-Patient EA Policies/Criteria

VelosBio will review all requests for investigational drug access on a case-by-case basis, taking into consideration regulations and guidance issued by applicable health authorities. Among other criteria, VelosBio will consider whether:

1. The patient has a serious, debilitating, or life-threatening medical condition for which no other medically appropriate treatment is available;
2. The patient’s healthcare provider can provide an assessment of the benefits and risks of the proposed expanded access use that suggests that the potential benefits of access to the investigational therapy likely outweigh known potential risks in the context of the risks posed by the patient’s underlying medical conditions;
3. The patient’s healthcare provider can provide relevant data (eg, medical records, etc.) to support the assessment of benefits and risks, considering standards of patient confidentiality appropriate for the situation;
4. The patient’s healthcare provider is currently licensed with the appropriate practitioner licensing board;
5. The patient’s healthcare provider is willing and able to support any regulatory procedures required by the relevant regulatory authority;
6. The patient’s healthcare provider is willing to enter into an expanded access agreement with VelosBio;
7. The patient’s healthcare provider will obtain informed consent from the patient or his/her legal guardian(s) for use of the investigational therapy;
8. The patient’s healthcare provider will supervise administration of the investigational therapy in accordance with any procedures specified by VelosBio (which in some countries may include a protocol for use of the investigational therapy);
9. The patient’s healthcare provider is willing and able to report any side effects of the investigational therapy and any other results as requested by VelosBio to assess benefits and risks of the expanded access use;
10. The patient does not qualify to participate in any ongoing clinical trial sponsored by VelosBio in an accessible geographical location;
11. Sufficient data exist to support the proposed expanded access use and the assessment of the benefits and risks of the expanded access use;
12. Access would not impede or compromise the ongoing clinical development program or regulatory approval of the investigational therapy; and
13. There is adequate supply of the investigational therapy to support access and such supply will not negatively affect a clinical trial or anticipated product launch

Requests for access to a VelosBio investigational therapy must be made by the patient’s treating physician. Whenever possible, the patient, the patient’s parent/legal guardian, or patient caregiver should work through the treating physician rather than contacting VelosBio directly.

To initiate a request for access to a VelosBio investigational drug, the physician should email info@velosbio.com. Such requests should aim to address Criteria 1-10 above. VelosBio will strive to respond to requests for access of an investigational product within five (5) business days of receiving a complete request that includes all necessary documentation.

Single-Patient EA Policies/Criteria

Venatorx Pharmaceuticals (the “Company”) is focused on conducting clinical studies and obtaining regulatory approval of investigational medicines in support of its mission to develop safe and effective treatments for infectious diseases.  The best way for patients to get access to investigational medicines is by taking part in clinical trials.  Please search ClinicalTrials.gov for publicly available information related to Venatorx’s ongoing clinical trials. 

It is recognized that not all patients are eligible to enroll in clinical trials. However, at this time, Venatorx is not able to offer Expanded Access (“EA”) and will not accept EA requests. 

Venatorx recognizes the need for EA programs.  The Company is currently establishing the necessary processes and procedures, as well as putting in place resources and supplies so that an EA program may be established in the future.

If you have questions about Venatorx’s EA policy, please contact medinfo@venatorx.com.

Available Therapies via Single-Patient EA

Cefepime/VNRX-5133 (taniborbactam)

Single-Patient EA Policies/Criteria

At this time, we are not yet providing Expanded Access.

Once our clinical trials have progressed to Phase 3 and we are able to provide Expanded Access, to be eligible for access to one of our investigational therapies via an Expanded Access mechanism, a physician must certify that the patient for whom the request is being submitted meets the following criteria*:
• The patient has received all available standard treatments without success
• The patient is not eligible to participate in any ongoing clinical study of a suitable investigational therapy
• The investigational therapy requested is part of an active ongoing clinical development program as described on our website
• Provision of the investigational therapy will not interfere with the ongoing development program, and the potential benefits to the patient outweigh the potential risks

* Note that meeting these criteria does not guarantee access to any investigational product.

Receipt of a request will be confirmed electronically within 48 hours. Following receipt of the request, we may require additional information as needed to complete our assessment. Once all of the necessary information is provided for review by our medical experts, a decision for expanded access will be communicated to the Physician within 10-15 business days.

Available Therapies via Single-Patient EA

At this time, we are not yet providing Expanded Access.

Single-Patient EA Policies/Criteria

At Viela Bio, we work every day to improve the lives of people impacted by serious, underserved, inflammatory and autoimmune diseases. We share the urgency of patients seeking new treatments for potentially life-altering diseases, and understand the interest in accessing our therapies outside of clinical trials and prior to regulatory approval.

Expanded access, also referred to as compassionate use, is a channel through which the US Food and Drug Administration (FDA) allows physicians to request investigational medicines for patients. We do not currently offer any expanded access programs, as we are focusing our resources – including supply of complex investigational medicines – on clinical trials and regulatory approval.

We encourage patients who are interested in accessing therapies in our pipeline to talk to their doctor about participating in a clinical trial. Information about all of our trials, including eligibility criteria and locations, is available at ClinicalTrials.gov.

If we are able to offer expanded access in the future, we will update this policy. If you have further questions, please email eap@vielabio.com.

Single-Patient EA Policies/Criteria

Expanded Access

Under certain circumstances, a person suffering a serious or life-threatening disease may ask to use an experimental treatment outside a clinical trial, before its safety and efficacy have been fully evaluated, and before the regulatory authorities have approved it. Generally, this is an option only for patients who have exhausted all available medical options and do not qualify for the ongoing clinical trials.

Vivoryon understands the intent of expanded access programs but, at this time, we can best advance the development of these potential promising products by enrolling patients in clinical trials which are designed to enable approval allowing access for the broader patient community. Our priority is to demonstrate the safety and effectiveness of varoglutamstat (PQ912), our investigational oral small molecule medicine in development to treat Alzheimer’s disease, in order to obtain regulatory approval and make it available to appropriate patients as rapidly as possible. We do this by running a thoughtfully designed and robust clinical trial program.

We are currently unable to offer expanded access for varoglutamstat (PQ912) and we believe that participation in one of our clinical trials is the most appropriate way to access our investigational therapies.

More Information

Treating physicians, patients and/or caregivers interested in learning more about Vivoryon’s investigational oral small molecule medicines currently undergoing clinical studies can find more information here or by or visiting www.clinicaltrials.gov and searching for Vivoryon Therapeutics.

If you are a health care provider who is interested in learning more about one of our investigational therapies, or a physician with questions about participation in one of our clinical trials, please submit a request to clinics@vivoryon.com. Vivoryon will acknowledge questions as soon as possible, usually within 5 business days of receipt.

If applicable, this website will be updated with hyperlinks to the relevant expanded access information on www.clinicaltrials.gov upon activation. As authorized by and in accordance with the 21st Century Cures Act, Vivoryon reserves the right to revise this policy at any time.

Single-Patient EA Policies/Criteria

At this time, vTv Therapeutics does not offer expanded access to any of our investigational drugs.