ACCESS TO INVESTIGATIONAL THERAPIES
Helping Eligible Patients Gain Access to Alnylam Investigational Therapies
Alnylam is dedicated to developing new therapies that have a positive impact on patient health, and to serving patients, patient families, and patient communities through education, empathy, and awareness.
We understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. In these circumstances, Alnylam will consider providing a requesting physician with access to a specific Alnylam investigational therapy, for the treatment of an individual patient outside of a clinical trial (compassionate use request), or through an Alnylam early access program (EAP) when certain conditions are met.
Early Access Programs
Early access programs are a means by which investigational therapies are made available, in certain circumstances, to treat patients with serious diseases who are unable to participate in an ongoing clinical trial or whose treatment options are otherwise limited.
Patients meeting the eligibility requirements for an EAP may be candidates to receive therapy; however, Alnylam cannot guarantee access to its investigational therapies. In addition to meeting eligibility requirements, a patient must be under the care of a physician trained on the administration of the drug at a selected medical establishment, and the patient must provide informed consent to participate in the program. Access to the investigational therapy will generally continue as long as the patient continues to receive benefit as determined by the treating physician and will end should the therapy become commercially available for the relevant indication in the patient’s country of residence. However, Alnylam reserves the right to discontinue, at any time, access to an investigational therapy.
For more information about early access, please contact Alnylam at EAP@alnylam.com.
Early Access Programs Currently Open
Givosiran for the treatment of acute hepatic porphyria (AHP) Learn More ›
Patisiran for the treatment of hereditary transthyretin-mediated (hATTR) amyloidosis Learn More ›
Lumasiran for the treatment of primary hyperoxaluria type 1 (PH1) Learn More ›