Pre-approval Access to IMPs

Ablynx Policy on Pre-Approval Access to Investigational Medicinal Products

Ablynx’s mission is to create new medicines which will make a real difference to the lives of patients. As part of that mission, Ablynx is firmly committed to advancing, as rapidly as possible, the development of the most promising Nanobodies®, and making them available to patients as soon as marketing authorization is granted by Regulatory Agencies.

The clinical trial process involves controlled testing in defined patient populations to establish the safety and efficacy of our investigational medicines. Regulatory Agencies then review all of the results in detail before deciding whether our products meet the criteria for approval.

Ablynx believes that it is in the best interest of patients to progress investigational medicines through the clinical development process and gain approval from Regulatory Agencies as expeditiously as possible.

However, some patients may benefit from early access to caplacizumab, before potential regulatory approval from authorities. Ablynx is therefore committed to exploring specific early access programmes in various geographies for these patients ahead of anticipated full approval from Regulatory Authorities. This involves negotiations with national health regulatory bodies in each geography to ensure Ablynx is compliant with safety guidelines, and setting up a sustainable manufacturing programme to ensure a stable and continuous supply of caplacizumab is available to these patients. Ablynx has already started working on these initiatives.

Any communication related to pre-approval access to investigational medicinal products should be sent to our Medical Department ( We will acknowledge receipt of all communications in 24h.