Please enable JS

Pipeline

Early/Expanded Access Policy

Momenta is committed to developing safe and effective medicines to treat rare immune-mediated diseases with high unmet medical needs. Our goal is to ensure access to our investigational drug, at the appropriate time and in a clinically appropriate manner for patients.

Momenta’s Early/Expanded Access Policy (EAP) refers to the use of an investigational drug outside of a clinical trial. This is initiated when the primary purpose is to diagnose, prevent, or treat a serious condition in a patient, which is different from a clinical trial where more comprehensive safety and efficacy data are collected. At Momenta, we recognize and understand the need for an early/expanded access policy.

A number of factors consistent with the US Food and Drug Administration (FDA) and other regulatory agencies' guidelines should be taken into account when considering this kind of access.


Momenta’s Key Eligibility Requirements

To be eligible to access Momenta's investigational drugs under the EAP, participants must meet certain requirements, including, but not limited to:

  • The illness must be serious or life-threating, with no other satisfactory treatment options (such as approved products or enrolling clinical trials)

  • There is sufficient evidence that the potential benefit to the patient would likely outweigh the potential risks, based on all available safety and efficacy information

  • Providing the investigational drug will not interfere with clinical trials that could support the investigational drug's development or marketing approval for the treatment indication


At this time, Momenta believes that participation in one of our clinical trials is the most appropriate way to access our investigational drugs. We do not currently provide our investigational drugs for use through expanded access.

If you are a patient who is interested in accessing our investigational drugs, please speak with your physician. You may also learn more about ongoing clinical trials by going to www.clinicaltrials.gov and searching for Momenta.

If you are a physician who is interested in learning more about our investigational drugs, or participating in our clinical trials, please submit a request to ClinicalTrialInfo@momentapharma.com.

 

Last Updated 2/11/2019