Halozyme’s Expanded Access Policy

Halozyme is committed to developing safe and effective therapies to transform the lives of patients with cancer. Our goal is to provide access to our investigational therapies at the appropriate time and in the correct manner for patients. To that end, we are currently conducting clinical trials on various potential indications for our investigational drugs.

A clinical trial is a research program conducted with patients to evaluate an investigational new drug in which comprehensive safety and efficacy data are compiled. Expanded access or “pre-approval access” refers to the use of an investigational new drug outside of a clinical trial by patients with serious or life-threatening conditions who do not otherwise meet the enrollment criteria for the respective clinical trial in progress.

A number of factors consistent with the U.S. Food and Drug Administration and other regulatory agencies’ guidelines should be taken into account when considering expanded access. They include:

  • The illness must be serious or life-threatening 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 available safety and efficacy information
  • Ability to provide a product in a fair and equitable manner, so that there is adequate manufacturing capacity for ongoing programs
  • Whether granting expanded access would potentially compromise the scientific validity of broader development programs, or interfere with or delay current clinical trials or regulatory filings designed to make the therapy available to many more patients

Halozyme believes that participation in one of our clinical trials is the most appropriate way to access our investigational therapies.

We are aware of state “Right to Try” laws and the recent passage of federal “Right to Try” legislation, and at this time, Halozyme is supporting access to investigational drugs by considering requests for Individual Patient INDs on a case-by-case basis. This approach preserves the FDA oversight of expanded access, safety, and the integrity of clinical trials.

For more information, consult the FDA website.

If you have additional questions, please speak with your physician or contact the Halozyme Medical Information Department at 1-844-855-4256 or medinfo@halozyme.com. We anticipate acknowledging receipt of requests sent to this email address within one business day.

In line with the 21st Century Cures Act, Halozyme may revise this policy at any time. This website and policy will be updated with a hyperlink or other reference to the expanded access record on www.clinicaltrials.gov after such record becomes active.

Notice

You are now leaving Halozyme.com. Halozyme is not responsible for or endorses the content of the linked site.

Ok