Catalyst Pharmaceuticals, Inc.

Expanded Access Intelligence

Official Statements

Score contribution: 100 3 supporting sources.

Score 1003 references
Featured Reference

This policy describes the principles and analysis that Catalyst Pharmaceuticals, Inc. (Catalyst) will use to determine whether to grant requests for Compassionate Use Access to the products it is developing.

While information about the process for Compassionate Use program eligibility can be addressed to Catalyst by anyone, formal requests for Compassionate Use access to Catalyst products may only come from licensed prescribers. It is expected, though not guaranteed, that all such requests will be reviewed and a decision made within 30 days.

One example of this is the Expanded Access Program (EAP) that we created for our lead product. Through the EAP, any patient in the United States, within the scope of allowed diagnoses, may access the product at no charge prior to FDA approval.

Past EAPs on ClinicalTrials.gov

Score contribution: 40 1 supporting sources.

Score 401 references
Featured Reference

Conditions: Congenital Myasthenic Syndrome, Lambert-Eaton Myasthenic Syndrome, Nystagmus, Acquired

Partner with Right2Hope

Right2Hope helps sponsors translate regulatory programs into actionable patient access pathways. Connect with our team to publish new programs, streamline intake workflows, or align with providers seeking compassionate use options.