Eiger is focused on developing medicines for patients with rare, life-threatening diseases. Clinical trials form the foundation of our development programs. These trials are designed to assess the safety and efficacy of investigational medicines. Participation in a clinical trial represents the best way, in a controlled setting, to gain access to an investigational medication.
Information about ongoing Eiger-sponsored clinical trials can be accessed by calling 1-650-272-6138. In some circumstances, a patient with a serious or life-threatening disease may not be able to participate in a clinical trial. Seeking use of an investigational medication outside of a clinical trial is permitted by the FDAand commonly referred to as Compassionate Use or Expanded Access. Our policy at Eiger is intended to comply with US Food and Drug Agency (FDA) requirements for any such use or access.
All requests should be sent via email to firstname.lastname@example.org. All requests will be acknowledged within 5 business days of receipt.
Eiger considers many factors when evaluating a request for expanded access of an investigational medicine, such as (but not limited to) the strength of the clinical data, the benefit-risk profile, the impact on the clinical development program, the phase of development, and probability and timing of regulatory approval.
A patient may be considered for expanded access to an investigational medicine based upon evaluation of the following minimum requirements (and others may apply based on the medicine and circumstances):
Eiger may revise the expanded access policies at any time.
Eiger BioPharmaceuticals, the distributor of the drug lonafarnib, is sponsoring a Managed Access Program (MAP) for eligible patients with Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) or a Progeroid Laminopathy (PL). The protocol governing this program can be viewed at ClinicalTrials.gov. The MAP study number is NCT03895528. Clinigen is the administrator of the lonafarnib MAP for HGPS and PL.
Patients or family members desiring more information about this program should speak to their doctors or contact The Progeria Research Foundation at 978-535-2594 or e-mail [email protected]. Patients and family members should not contact Clinigen. Clinigen is only authorized to speak with doctors.
For treating doctors with questions about the MAP, please contact Clinigen’s Medicine Access Team at +44 (0) 1932 824123 or email [email protected]. The doctor may also e-mail Eiger at ProgeriaMA@eigerbio.com or Eigeraccess@eigerbio.com.