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Our Patient Commitment

As the end-user of our products and services, we are dedicated to improving the quality of life of our patients suffering from a variety of blood clotting disorders, immune deficiencies, and other illnesses. By working closely with patients and patient associations in the United States and around the world, we are able to develop a better, more empathetic understanding of our patients’ needs and challenges. We then leverage this knowledge to further innovate and improve our products themselves and the overall patient experience.

 

The safety record of Octapharma products provides a sense of confidence to both patients and healthcare professionals alike. Octapharma has pioneered the adoption of the solvent-detergent (S/D) treatment process for viral inactivation, which according to the World Federation of Hemophilia is the current gold standard for safety from highly infectious enveloped viruses, and “should be seriously considered as the option of choice when assessing products.” The S/D process in conjunction with other critical steps in the broader viral inactivation process, have collectively delivered our enviable record of no known viral transmissions over the last three decades.

 

At Octapharma, patient safety is critically important and is never left to chance. Our enviable history and proven track record are a function of a highly rigorous process that begins with our plasma source. All blood donors, collection centers, and donated blood or plasma are held to the highest standards. Once received in our facility, a highly precise and multi-stage virus inactivation process takes over before releasing finished products for use in patients.

Octapharma USA Expanded Access General Policy

Octapharma is dedicated to improving the lives of patients.  Patients with serious illnesses who have exhausted all available treatment options often are interested in knowing if their condition could be treated with investigational drugs/biologics that have not yet been approved by the United States Food and Drug Administration (FDA).  In such cases the patient might ask if and how they can receive early access to Octapharma investigational products that might be helpful for their condition.

Under the 21st Century Cures Act, the manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available its policy on how it evaluates and responds to requests submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act for provision of such a drug.  This webpage sets forth Octapharma USA’s expanded access policy on investigational products intended to treat serious diseases.  In certain instances, an Expanded Access Program for a particular investigational product may be available to patients in these circumstances.

1. Clinical Trials

Octapharma is required to collect data on the safety and effectiveness of any new biologic product in clinical trials and submit trial results to the FDA before the product can be legally marketed. To participate in a trial, a patient must conform to certain entry or exclusion criteria.  A clinical trial is primarily designed for data collection; outcomes for any particular patient are not guaranteed.  Further, participation in any clinical trial inherently involves certain risks.  Thus, an important step in trial enrollment involves the patients’ signature on an “informed consent” form.  A list of all Octapharma clinical trials can be seen at:

www.clinicaltrials.gov

When clinical trial records containing information about expanded access to Octapharma’s investigational products become publicly available pursuant to section 402(j)(2)(A)(ii)(II)(gg) of the Public Health Service Act, Octapharma will add a hyperlink or other appropriate reference to those records on this website page. 

2. Expanded Access (“Compassionate Access”)

In cases where a clinical trial is not an option and the patient has exhausted all available treatment options, the FDA may give permission for Octapharma to provide a treating physician with an unapproved drug to administer to the patient, outside of any ongoing clinical trial. Such individual use of an unlicensed investigational drug is called “expanded access.”

If you would like to inquire about expanded access for any of Octapharma’s products that have investigational status, please have your treating physician contact the Octapharma USA Vice President Scientific & Medical Affairs at telephone 888-429-4535 or by email at usmedicalaffairsanti spam bot@octapharmaanti spam bot.com.  Please submit sufficient supporting detail to enable Octapharma to evaluate the expanded access request.  For physicians who are contacting Octapharma regarding expanded access, please include your contact information so that Octapharma may follow up with you directly.

To be eligible for access to an investigational or unlicensed product, the following conditions must be met:

·The patient must have a serious or immediately life-threatening disease or condition.

·The patient must have undergone any existing and appropriate standard treatments without success.

·The patient must be ineligible or unable to participate in any ongoing clinical study of the investigational drug, including being unable because of a lack of access due to geographic limitations.

·Octapharma must have sufficient supplies of the investigational product to meet the needs of the expanded access program without impairing Octapharma’s clinical trials.

·The patient must meet any other pertinent medical criteria for access to the investigational or unlicensed drug, as established by the Octapharma medical professionals working on the drug development program.

·The disease or indication for which the investigational product is being sought is well understood.

·The potential benefit to the patient of using the investigational product must outweigh the collective potential risks to the patient, based on the data and other information available to Octapharma professionals working on the drug development program at the time of the request for expanded access.

·Sufficient clinical data must be available to identify an appropriate dose for the requested use.

Octapharma USA strives to acknowledge receipt of expanded access requests within no more than one business day of receipt of the request and all required medical documentation for the patient.  The U.S. Food and Drug Administration strives to respond to such requests as quickly as possible and typically within two business days.

As authorized by the 21st Century Cures Act, Octapharma may revise this expanded access policy at any time.  Additionally, the posting of this policy by Octapharma shall not serve as a guarantee of access to any specific investigational drug by any individual patient.