Welcome to Novo Nordisk in the United States


Expanded Access

How we approach expanded access

At Novo Nordisk, we're committed to discovering and developing innovative medicines for diabetes and other serious chronic conditions. Sometimes, patients may wish to access investigational medicines that are not yet approved by the U.S. Food & Drug Administration (FDA). The most appropriate way patients could access these medications is through our clinical trials. Clinical trials are designed to determine whether an investigational medicine is safe and effective for patients, and are overseen by a team of medical experts. In cases where enrolling in a clinical trial is not possible, expanded access to an investigational medicine may be requested for individual patients on a case by case basis.

Expanded access programs may be appropriate for a patient confronting a serious or life threatening condition, who has no other available medical option and does not qualify for a clinical trial. Novo Nordisk may consider certain requests when they meet these conditions:

  • The patient has a serious or life-threatening illness
  • The investigational drug is under active clinical development
  • The patient is ineligible for or otherwise unable to participate in clinical trials
  • The potential benefit to the patient should outweigh potential risks
  • The patient failed all approved treatments, or there is no other approved treatment option available

These criteria are derived from industry standards and form the basis for our approach.

 

Requesting access

To submit a request for an investigational medicine outside of a clinical trial, the treating physician can email us here. We will respond within five (5) business days.