Expanded Access Programs
We strive to bring transformative therapies to those who most need them
According to current legislation, the information you need to see is considered information directed exclusively to the healthcare profesional.
In our aim to provide significant differential value to people suffering from serious illnesses, we are directing our efforts to developing products in two main therapeutic areas: pulmonary vascular and interstitial lung diseases and neurological disorders.
Both areas include rare or low-prevalence diseases that are often lacking in appropriate or authorised treatments. Accordingly, Ferrer's commitment to the research and development of potential solutions in these areas through clinical trials is crucial for improving the lives of people affected, as well as for efficiently managing healthcare resources.
And our commitment goes even further. We recognize there are circumstances where patients with a severe or immediately life-threatening disease have no comparable or satisfactory alternative therapy options available, enrollment into a clinical trial is not possible, and the potential benefits of treatment outweighs the potential risks. In such circumstances, at Ferrer, we also offer eligible candidates the possibility of benefitting from therapies outside of clinical trials and before approval through Expanded Access Programs (EAPs).
What is an Expanded Access Program (EAP)?
Expanded Access Programs (including “Compassionate Use”, "Early Access", "Managed Access", "Named Patient Programs [NPPs]", among others), are potential pathways for people with an immediately life-threatening condition or serious disease to obtain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Who can join an EAP?
Expanded access may be appropriate when all the following apply:
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The person has a life-threatening, long-lasting or seriously debilitating illness.
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The disease cannot be treated satisfactorily with any currently authorised medicine.
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Patient enrollment in a clinical trial is not possible.
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Sufficient data exists to believe the potential benefit of treatment outweighs the potential risk in the context of the disease to be treated.
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Ferrer has adequate supply of the investigational product and expanded access will not interfere with ongoing clinical trials or with development of the product.
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Such access provision is allowed as per local laws and regulations.
Process for Requesting Expanded Access
The treating physician may request information about applying for access to Ferrer’s investigational or pre-approval products, by contacting Ferrer Medical Information by email at medinfo@ferrer.com. Ferrer experts will review all expanded access requests carefully and fairly in consideration of the above criteria and applicable local laws and regulations.
Additionally, specific expanded access program information can be found below for some individual Ferrer products:
Expanded Access Program for pulmonary hypertension associated with interstitial lung disease (PH-ILD)1,2
Interstitial lung disease (ILD) is a group of lung diseases that are characterised by marked scarring or fibrosis of the bronchioles and alveolar sacs within the lungs. Increased fibrotic tissue in ILD prevents oxygenation and free gas exchange between the pulmonary capillaries and alveolar sacs, and the condition can present with a wide range of symptoms, including shortness of breath with activity, laboured breathing and fatigue.
WHO Group 3 Pulmonary hypertension (PH) frequently complicates the course of patients with interstitial lung disease and is associated with worse functional status measured by exercise capacity, greater supplemental oxygen needs, decreased quality of life and worse outcomes.
Ferrer works to guarantee successful delivery of the EAP safely to eligible candidates.
The information contained in this website is provided for informational purposes only. By clicking on this link, you will be re-directed to an external website, out of the control of Grupo Ferrer Internacional S.A or any of its affiliates. Ferrer does not take any responsibility for the contents and information of this external website, which may not comply with applicable regulations in the country of your origin
DISCLAIMER: The fact that there is an existing program does not guarantee it will be available everywhere. Every country has its own regulatory mechanisms to facilitate EAPs to new medicines and any pre-approval access to them must always comply with the specific laws and regulations of each given territory, including the requirements to import foreign medicines.
References:
1. Behr J, Nathan SD. Pulmonary hypertension in interstitial lung disease: screening, diagnosis and treatment. Curr Opin Pulm Med. 2021 Sep 1;27(5):396-404.
2. King CS, Shlobin OA. The trouble with group 3 pulmonary hypertension in interstitial lung disease: dilemmas in diagnosis and the conundrum of treatment. Chest. 2020;158(4):1651-1664.