We are committed to providing safe, fair and sustainable patient access to its products at different stages of lifecycle development.
Portola Pharmaceuticals Inc. is a biotechnology company charting a new course in the treatment of serious blood-related disorders. The first step in new drug development is to conduct clinical trials to assess safety, tolerability, and efficacy of the medicines. Portola is currently at this phase of development for its investigational therapies.
Expanded access and compassionate use programs allow patients to gain access to investigational medicines outside of a clinical trial. Under the 21st Century Cures Act, the manufacturer of a drug for a serious disease or condition may provide the drug to eligible patients under certain conditions. Portola is not making its unapproved drugs available on an expanded access basis at this time. In order to ensure appropriate access to Portola’s investigational medicines and to safeguard the welfare of patients, it has determined that the best course is to first confirm that its investigational medicines are safe, tolerable, and effective through controlled clinical trials.
In the event that Portola decides to make its products available on an expanded access basis, this policy will be updated with a hyperlink to the relevant expanded access record(s) on www.clinicaltrials.gov after such record(s) becomes active.
Portola reserves the right to update or revise its expanded access policy at any time. For information on any updates or changes to Portola’s expanded access policy and current clinical studies, please visit www.clinicaltrials.gov or www.Portola.com. Portola’s publication of this current policy or any future policy shall not serve as a guarantee of access to any specific investigational drug by any individual patient.