Protalix Biotherapeutics Inc. (NYSEAMERICAN: PLX) and Cheisi Global Rare Disease have offered a regulatory update about pegunigalsidae alfa (PRX-102) for the proposed Fabry disease treatment. The update included the announcement of the receipt of the Type A meeting minutes from the FDA regarding the complete response letter received for PRX-102 BLA confirming the pathway for resubmission of PRX-102 BLA.
Protalix receives Type A meeting minutes for BLA resubmission
Dror Bashan, Protalix’s CEO and President, said, “We are pleased with the results of the Type A meeting. We remain committed to the Fabry community and our goal of providing an alternative treatment option for Fabry patients.”
The meeting took place on September 9, 2021. The FDA agreed in principle that the proposed data package for the BLA resubmission has the potential of supporting a traditional PRX–102 approval for the Fabry disease treatment, according to the meeting minutes issued by the FDA. Given the new regulatory landscape in the US, the intended data package for the BLA resubmission will include analysis of the phase III BALANCE clinical study.
Protalix’s SVP and Chief Development Officer Einat Brill Almon said, “We are encouraged by the productive discussion with the FDA, which we believe provides a pathway to resubmit the PRX–102 BLA, and appreciate the valuable feedback and guidance provided. We look forward to our continued development of PRX–102 and our collaborative efforts with Chiesi in advancing the PRX–102 program towards commercialization.”
Protalix and Chiesi met EMA regarding MAA in the EU
The companies also announced a meeting with the European Medicines Agency held on October 8, 2021, about PRX-102, during which the scope of expected MAA for EU was discussed.
Chiesi Global Rare Diseases Head Giacomo Chiesi said, “On behalf of our team at Chiesi, we thank the patients, families and clinicians for their participation in our clinical studies evaluating PRX–102. We remain committed to advancing this important program to expand support for the Fabry disease community.”