EARLY ACCESS PROGRAM FOR LUMASIRAN

Lumasiran is a subcutaneously administered RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding glycolate oxidase (GO) – for the treatment of primary hyperoxaluria type 1 (PH1). Where it is approved, it is marketed as OXLUMO (lumasiran).

Eligibility Requirements

To be eligible to seek access to lumasiran through the early access program (EAP), participants must meet certain requirements, including, but not limited to:

  • Patients of all ages with a documented diagnosis of PH1.
  • Not currently enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives, whichever is longer, since ending another investigational device or drug study(s) or receiving other investigational agent(s)
  • Not previously dosed with lumasiran in a clinical study.
  • No history of liver transplant.
  • No medical conditions or comorbidities which, in the opinion of the physician, would interfere with Program compliance or the patient’s safety.

 

Only a licensed physician can request lumasiran. If you are a patient living in a country where lumasiran is not commercially available and are interested in seeking access to lumasiran through the early access program, please speak to your physician. Alnylam can only respond to a physician requesting access to lumasiran on behalf of a patient in his/her care.

 

If you are a physician who is seeking to obtain access to lumasiran for a patient in your care, please contact eap@alnylam.com

 

If you are a physician or patient and have a medical question, please contact medinfo@alnylam.com.

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