Expanded Access Policy

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Mitsubishi Tanabe Pharma Group Companies Policies and Procedures for Evaluating and Responding to Requests for Expanded Access to Our Investigational Drugs

As organizations focused on advancements for serious and rare disorders, Mitsubishi Tanabe Pharma (MTP) group companies are committed to taking on the challenges of complex and debilitating conditions to help meet the needs of people suffering from serious and often life-threatening illnesses. Today, we are focused on driving scientific discovery in many areas, including amyotrophic lateral sclerosis (ALS) and Parkinson’s disease.

MTP group companies believe the current system for getting new treatments to patients, through participation in company sponsored studies, generates important safety and efficacy information needed to obtain approval and provide broader access to those in need, and is a responsible option for administration of unapproved therapies. For this reason, MTP group companies do not at this time have any Expanded Access program in place.

Contact Information

The MTP group companies currently have no Expanded Access program and are not actively accepting requests from healthcare providers for compassionate use. The following is the contact information at the MTP group companies for medical questions:

1-888-292-0058

Clinicaltrials.gov

In the event any of the MTP group companies initiates an Expanded Access program, this website policy will be updated to notify the public with a hyperlink or other reference to the clinical trial record containing the required information about the expanded access for such drug.

Nothing herein shall prevent the MTP group companies from revising this policy at any time.