Biohaven is a clinical-stage biopharmaceutical company dedicated to the development of innovative drugs targeting neurological diseases, including rare disorders like ALS. We are proud to be able to offer an Expanded Access Program with BHV-0223, a sublingual formulation of riluzole, to eligible patients with ALS for whom other treatment options are insufficient. Clinical trials are the best way to understand a drug's efficacy and safety. Patients entering clinical trials are required to meet specific criteria. For those patients who do not meet these criteria, or if a clinical trial is not available, Expanded Access may be one path for patients to receive our investigational medicines.
Requesting Expanded Access
All requests for Expanded Access must be made by a treating physician on behalf of a patient. Biohaven is committed to a fair and impartial evaluation of each request for access to our investigational medicines. No patient is guaranteed entry into the program by applying. Requests will be acknowledged within two business days.
Biohaven has opened an Expanded Access Protocol for BHV-0223 for Amyotrophic Lateral Sclerosis (ALS). The protocol has been reviewed by the FDA and approved by an IRB.
If you are a physician and would like more information on the Expanded Access Protocol, additional information is available on www.ClinicalTrials.gov (NCT03537807) or by contacting us at BHV0223.ExpandedAccess@earlyaccesscare.com and by calling 1-(888) 315-5797 (option 6).
At this time no other Biohaven investigational drug in development is available by Expanded Access.
Information about the Expanded Access Program for BHV-0223 is found here.
Infographic for physicians is located here.
Biohaven Pharmaceuticals Expanded Access Policy Position