Company Directory

Single-Patient EA Policies/Criteria

Ultimovacs is currently unable to offer an Expanded Access Program to patients

Available Therapies via Single-Patient EA

There are no investigational products available for Expanded Access

Disease/Category-Specific EA Policies/Criteria

https://ultimovacs.com/expanded-access

Single-Patient EA Policies/Criteria

Requests for early access to investigational therapies must be made by a qualified physician.

Single-Patient EA Policies/Criteria

At this point of clinical development, UNION has not established an Expanded Access Program that allows patients access to orismilast outside of clinical trials. Participation in clinical trials will ensure dedicated monitoring of the efficacy and safety of the drug, which is currently the most appropriate and responsible setting of patient treatment.

Disease/Category-Specific EA Policies/Criteria

https://uniontherapeutics.com/wp-content/uploads/2023/01/UNION-therapeutics_Expanded-Access_final.pdf

Single-Patient EA Policies/Criteria

Licensed physicians should submit expanded access requests to Usona at EA@usonainstitute.org using the Usona Expanded Access Request Form. Requests for Expanded Access will be acknowledged within 5 business days of receipt. All Expanded Access use requests will be decided on a case-by-case basis at the sole discretion of Usona. All requests received will be reviewed anonymously by an internal Usona Committee to ensure patient safety and equality. The licensed treating physician must obtain, where applicable, all Ethics Review Board (ERB) or Institutional Review Board (IRB) approvals along with approval from the overseeing regulatory authority (e.g. FDA, EMA, Health Canada, etc.) prior to submission.

Expanded Access requests to Usona must meet ALL of the following criteria in order to be considered:
• The disease or condition for which use is requested is serious or life-threatening;
• The patient is ineligible or not able to participate in a clinical trial for the requested use and all approved treatment options have been exhausted without success and no satisfactory alternative treatment is available as determined by the requesting licensed physician;
• The requesting physician is a licensed physician and is authorized to deliver treatment as outlined in the request;
• There is sufficient clinical evidence to inform the safe use of the investigational drug under the requested use (at the requested dose and frequency of treatment);
• There is sufficient clinical evidence to suggest the requested use is expected to provide a potential clinical benefit to the patient (at the requested dose and frequency of treatment);
• The requested use would not negatively impact or interfere with active clinical trials or drug development programs of the applicable investigational drug;
• The treating physician has received approval by their overseeing regulatory authority (e.g. FDA, EMA, etc.) and where applicable, any Ethics Review Board (ERB) or Institutional Review Board (IRB) approvals
• The requested use complies with all applicable laws, rules and regulations;
• The requested use complies with Usona’s policies, including strict adherence to the ‘Usona Expanded Access Set and Setting Manual’;
• There is an adequate supply of the requested investigational drug available for the requested use.

Please note that Usona is only able to respond to Expanded Access requests from licensed physicians. Additional requirements apply to Expanded Access use of controlled substances, including specific personnel and facility requirements for expanded access use of drugs of the psychedelic drug class.

Available Therapies via Single-Patient EA

Psilocybin capsules (25 mg)

Disease/Category-Specific EA Policies/Criteria

https://www.usonainstitute.org/expandedaccess/

Single-Patient EA Policies/Criteria

US WorldMeds is committed to serving patients by providing safe, fair, and sustainable patient access to its medicines. USWM may be able to provide patients access to its investigational drug, DFMO (also called eflornithine or difluoromethylornithine), outside of a clinical trial if certain conditions are met and if permitted by local law and regulation. The use of an investigational medical product (i.e., one that has not been approved by the Food and Drug Administration [FDA]) outside of a clinical trial is known as Expanded Access (sometimes referred to as “compassionate use”). Generally, there are two types of Expanded Access—Group Expanded Access and Individual Patient Expanded Access. For more information on the different types of Expanded Access, visit the following FDA website: https://www.fda.gov/news-events/public-health-focus/expanded-access.

USWM collaborates with Beat Childhood Cancer Research Consortium (BCC) and Sponsor-Investigator, Dr. Giselle Sholler and makes investigational product DFMO 192 mg tablets available for pediatric oncology indications through multiple clinical trials and a Group Expanded Access Program (also called Intermediate Population Expanded Access).
USWM does not currently provide Individual Patient Expanded Access; however, detailed written requests for unique circumstances will be reviewed on a fair and equitable basis.

Expanded Access may not always be available. Information about the Group Expanded Access Program, including a full list of eligibility criteria and site contact information can be found here: https://clinicaltrials.gov/ct2/show/NCT03581240. In addition to meeting the eligibility criteria outlined at the link above, the following criteria must be met for entry into the Group Expanded Access Program:

• USWM must have sufficient supply of DFMO to reasonably accommodate the anticipated duration of treatment.
• The patient’s licensed physician must be willing to collaborate with the enrolling center.
• The patient’s physician and enrolling physician determine there is no comparable or satisfactory therapy available to treat the patient’s disease or condition and they agree that the patient is clinically stable and able to receive this medication.
• The patient’s parent/guardian is willing to travel with the patient to BCC at study entry and every three months while on treatment.

Licensed physicians may contact USWM with general requests or questions regarding Expanded Access at regulatoryaffairs@usworldmeds.com. USWM will endeavor to acknowledge general requests and questions within 5 business days. In line with the 21st Century Cures Act, USWM cannot guarantee access to investigational product to all patients. USWM may revise this policy at any time; at such time, the revised policy will be made publicly available.