Patients facing life-threatening, chronic or seriously disabling illnesses or diseases live with the hope that tomorrow will bring a new medicine to extend and improve their lives. Merck KGaA, Darmstadt, Germany, and Pfizer are committed to developing new medicines for patients with such illnesses and diseases.
Our companies believe the best way to fulfill this commitment is to conduct clinical studies to assess the safety and effectiveness of experimental medicines which, if proven, will allow us to obtain drug approval from regulatory authorities and provide patients with broad access to these new medicines.
We believe that patients should be encouraged to participate in clinical studies, the goal of which is to secure approval of new, safe and effective medicines for the broadest number of patients.
To find a clinical study, go to clinicaltrials.gov (for all sponsors, including Merck KGaA, Darmstadt, Germany, and Pfizer)
However, we understand that patients with life-threatening, chronic or seriously disabling illnesses and diseases may be ineligible or unable to participate in a clinical study and may want access to the experimental medicine being tested in the clinical study.
We also understand that patients may want the medicine after a clinical study ends but before marketing authorization is granted. These different scenarios are covered by the Early Access Program.
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Although these types of programs are known by many different names around the world - such as Named Patient Programs, Named Patient Supply, Compassionate Use, Single Patient IND, Authorisations Temporaires d’Utilisation, Special Access Programs; Named Patient Access, and Special Access Schemes - "Early Access" is the term that we use to encompass all of these possibilities.
Experimental medicines have not yet received regulatory approval and so their potential risks and benefits have not yet been fully established.
Merck KGaA, Darmstadt, Germany, and Pfizer encourage patients to consult their physician to determine the best course of action depending on their individual needs and the assessment of all possible benefits and risks associated with use of an unapproved product.
We will consider providing patients with access to an experimental medicine outside of a clinical study in accordance with applicable laws and regulations based on the assessment of the following principles:
- The patient has a life-threatening, chronic or seriously disabling illness or disease.
- The patient should have exhausted all available therapeutic options typically used to treat the illness or disease, or should no longer be able to tolerate such treatments.
- The patient is ineligible for, or otherwise unable to participate in, clinical studies.
- The potential benefit to the patient should generally outweigh the combined potential risks of the experimental medicine and the outcome of the illness or disease itself.
The patient should meet any specific medical criteria defined for access to the experimental medicine.
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At this time Merck KGaA, Darmstadt, Germany, and Pfizer are considering Early Access requests for the following indications:
- Treatment of adult patients with metastatic Merkel cell carcinoma (mMCC) whose disease has progressed after receiving at least one prior chemotherapy
PAREXEL is managing the Early Access Program for avelumab on behalf of our companies. If you wish to make an inquiry into the availability of Early Access in your respective country, please start the physician registration process using the link below.
The PAREXEL team will guide you through the process, including an evaluation of the availability of Early Access in your country.
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