This policy applies to expanded access and compassionate use requests for investigational products with active ingredients that have not been approved for any purpose in the country from which the request originates, or are otherwise not available in that country through normal commercial channels. For purposes of this policy, an expanded access or compassionate use request is any request for the use of an investigational product outside the scope of a clinical study. Galectin Therapeutics’ development resources are focused on conducting clinical studies and obtaining regulatory approval of investigational products. Galectin Therapeutics is also committed to making reasonable accommodations so that seriously ill patients who have exhausted other appropriate treatment options may, under the conditions described in this policy and in accordance with applicable local law, have appropriate access to investigational products before they are commercially available. Galectin Therapeutics-sponsored clinical studies, open label safety studies, and continuation phases of clinical trials are out of scope of this policy. It is important to note that in the European Union (EU), the term ‘expanded access program’ generally refers to a program run as a clinical trial.
Galectin Therapeutics Inc. considers expanded access and compassionate use requests only when all of the following criteria are met:
- The investigational product is being studied under an appropriate regulatory authorization or all investigational studies of the product have been completed;
- The patient(s) for whom expanded access or compassionate use is sought:
- Is suffering from a serious disease or condition;
- Has undergone appropriate standard treatments without success, no comparable or satisfactory alternative treatment is available or no standard treatment exists for the disease or condition;
- Is ineligible for participation in any ongoing clinical study of the investigational product; and
- Meets any other relevant medical criteria for compassionate use of the investigational product, as established by Galectin Therapeutics.
- There are meaningful human clinical data to support an assessment that the potential benefits to the patient outweigh the risks to the patient. In practice, this will generally occur at a point when Galectin Therapeutics’ management has made a decision to seek marketing approval in one or more countries;
- Providing the investigational product for expanded access or compassionate use will not interfere with development of the product;
- The physician attending to the patient(s) for whom expanded access or compassionate use is sought agrees to comply with all applicable legal and regulatory requirements in relation to the request and any requirements in terms of medical criteria, safety reporting or other data provision which the relevant study team may require.
In general, where permitted by local regulation, expanded access or compassionate use treatment will be discontinued when the product becomes commercially available in that location. If a patient does not have any possible access (e.g., due to geographic limitations) or if they have already failed to respond to the active comparator of a clinical trial with the unapproved product, they may be considered for compassionate use on a case-by-case basis. Galectin Therapeutics will review compassionate use requests on a fair and equitable basis in accordance with the principles set forth in this policy. When requests are granted (i.e., expanded access or compassionate use), relevant documentation regarding the use and safety of investigational product must be provided to the treating physician (e.g., investigator brochure, labeling documentation, protocol). Named patient use and single patient compassionate use do not generally require monitoring. Monitoring of other expanded access and compassionate use programs must be carried out where required by and in accordance with local law and regulation.
Galectin Therapeutics may, at any time, revise this Compassionate Use Policy by update of this posting. Any changes will be posted on this page. This Compassionate Use Policy was last updated on July 24, 2017.