Protalix BioTherapeutics Inc. (NYSEAMERICAN:PLX) and Chiesi Global Rare Diseases have announced that they have submitted a Biologics License Application to the FDA for pegunigalsidase alfa (PRX-102). The companies submitted the BLA on May 27, 2020, for PRX-102 as a potential Fabry disease treatment in adult patients through the Accelerated Approval Pathway.
BLA submission to accelerate clinical development of PRX-102
In January 2018, the FDA granted PRX-102 Fast Track designation. PRX-102 is the Protalix’s purposefully-developed acting recombinant PEGylaed that has been cross-linked with α-galactosidase-A, which is an investigational product candidate.
The company’s BLA submission comprises a comprehensive combination of preclinical, clinical, and manufacturing data from the company’s first and second phase clinical studies. The PRX-102 trials include the linked extension study that succeeded in the Phase I/II study, interim Phase II BRIDGE clinical data, and safety data from the current PRX-102 clinical studies. If the FDA approves the BLA, then Protalix will qualify for a milestone payment from its partner, Chiesi.
Dror Bashan, the CEO of Protalix, indicated that they were delighted with the assistance the FDA has accorded the company resulting in the BLA submission through the Accelerated Approval pathway. Bashan added that together with Chiesi, they look forward to working with the FDA to get marketing approval for pegunigalsidase alfa. According to Bashan, Protalix is committed to innovate and bring a new treatment alternative to patients with Fabry disease.
The Chiesi and Protalix partnership will help deliver treatment for Fabry disease
On the other hand, Chiesi Global Rare Diseases’ head Giacomo Chiesi indicated that the BLA submission to the FDA is a huge milestone for Cheisi’s Global Rare Diseases division. Cheisi established the division at the beginning of this year to enhance the company’s focus on bringing a difference to the Fabry patient community.
Giacomo added that collaboration and partnership with Protalix is an indication of how the company can leverage its global reach and expertise in drug development. This is aimed at helping patients and families living with rare diseases such as Fabry disease.