Protalix Fabry Disease Expanded Access Policy
Expanded Access Policy
Enrollment to Protalix’s existing, on-going clinical trials with pegunigalsidase alfa has been completed.
Patients may be eligible for treatment with pegunigalsidase alfa through an Expanded Access Program (EAP). The objective of this EAP Policy is to provide guidance as to how to seek access to pegunigalsidase alfa through the EAP
Protalix may not be able to provide expanded access to all requesting physicians and patients. Factors that may lead to a denial of expanded access may include: availability of product; applicable country or other rules and regulations prohibiting the supply of product; customs and import restrictions into the requesting country or jurisdiction; lack of medical expertise; and patients not meeting the inclusion criteria or taking other drugs that prohibit the use of the product. Other limiting factors may also apply
Existing Expanded Access Programs
In the United States:
Pegunigalsidase Alfa (in collaboration with Chiesi Global Rare Diseases)
ClinicalTrials.gov Identifier: NCT04552691
Treating physicians should request access on behalf of their patients by submitting a patient request on Chiesi’s online portal: https://chiesi.versaic.com.
Questions about the pegunigalsidase alfa EAP and inquiries outside the US can be sent to: GRD.EAP@Chiesi.com
Contact for all other Expanded Access inquiries
Dr. Raul Chertkoff