Expanded Access Programs

We strive to bring transformative therapies to those who most need them

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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. At Ferrer, we also offer eligible candidates the possibility of benefitting from therapies outside of clinical trials and before regulatory approval through Expanded Acess Programs (EAPs).

What is an Expanded Access Program (EAP)?

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. 

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Criteria

Who can join an EAP?

 

Expanded access may be appropriate when all the following apply:

  • The person has a life-threatening, long-lasting or seriously debilitating illness.

  • The disease cannot be treated satisfactorily with any currently authorised medicine.

  • Patient enrollment in a clinical trial is not possible.

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Tyvaso EAP

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.

SUBMIT A REQUEST

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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.