Boehringer Ingelheim Pharmaceuticals

“Boehringer Ingelheim supports Expanded Access Programs (EAPs) as an important way of allowing patients access to investigational medicines prior to FDA approval.”

“For appropriate patients with serious, life-threatening diseases unable to participate in a clinical trial, our compassionate use programs is designed to potentially provide access to selected medications before they complete the full regulatory review process. Our patient access programs include compassionate use programs for groups of patients with a condition that Boehringer Ingelheim is researching, single patient use requests outside our current scope of investigation, and in some countries such as the United States, Expanded Access Programs where groups of patients with a particular condition are enrolled in a treatment protocol.”

“Boehringer Ingelheim has a process that adheres to the country laws and regulations where this is allowed although we may not have a compassionate use program for all medications that we are researching.”

“We have a clearly defined process for granting access to our drug candidates. If the patient meets certain criteria, his or her doctor can send a request for compassionate use to Boehringer Ingelheim. The form is available from Boehringer Ingelheim Medical Professionals around the world on our website. Once it has been submitted, a committee of in-house experts then carefully reviews the request and does its best to get back to the patient’s doctor within seven days. Requests that are more complex may require additional consultation and discussion with external experts including an independent bioethics committee.”

Boehringer Ingelheim’s position on compassionate use of investigational medications.

Answers to common questions from both patients and health care professionals regarding Compassionate Use of experimental medications. Potential access to selected medications for appropriate patients with serious, life-threatening diseases unable to participate in a clinical trial

The pooled analysis was based on global clinical outcome data from 693 patients with NSCLC driven by uncommon EGFR mutations, who received afatinib as part of clinical trials, compassionate use or expanded access programs, phase IIIb trials, non-interventional trials and case series/studies in more than 40 countries.