Introduction and definitions
Participation in clinical trials is the most common method to get access to investigational medicinal products that are not approved. Clinical trial participants are closely monitored as part of the clinical trial. Clinical trials participation also contributes to improved scientific understanding of the investigated diseases and medicinal products and can therefore lead to approval of new future medicines.
For more information about clinical trials please see ClinicalTrials.gov.
Expanded access, which also is called compassionate use, is the provision of unapproved investigational medicinal products to patients with serious or life-threatening conditions, who do not qualify for clinical trials on an individual basis.
Abliva’s expanded access policy
Abliva is currently not actively running any expanded access programs. The reasons for this include the nature of the diseases for which Abliva is developing drugs as well as the early stage of development of these products, as outlined below.
NeuroSTAT: This investigational medicinal product is intended as treatment in the acute phase (within hours) following a traumatic brain injury, which requires that the product is available at the time of arrival to the hospital. Individual requests for expanded access are thus not possible.
Mitochondrial disease products: These investigational medicinal products are currently in early clinical development or non-clinical development and therefore not enough information is currently available to enable expanded access.
The investigational medicinal product, KL1333, is currently in clinical development for specific mitochondrial disease spectra with defined genotypic causes and phenotypic disease expressions. The details of the clinical study/ies are/will be posted on ClinicalTrials.gov. Patients eligible for such study participation should contact participating sites for further information. At this time, expended access outside this intended study population is not foreseen.
The investigational medicinal product, NV354 is about to enter early clinical development and therefore there is not enough information is currently available to enable expanded access.