logo
Plus   Neg
Share
Email

Protalix Submits BLA To FDA For Pegunigalsidase Alfa For Treatment Of Fabry Disease

Protalix BioTherapeutics Inc. (PLX), together with its development and commercialization partner Chiesi Global Rare Diseases, announced the submission of a Biologics License Application to the U.S. Food and Drug Administration for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease via the FDA's Accelerated Approval pathway.

Pegunigalsidase alfa, or PRX-102, was granted Fast Track designation by the FDA in January 2018. Pegunigalsidase alfa is the Company's purposefully-designed, long-acting recombinant, PEGylated, cross-linked a-galactosidase-A investigational product candidate.

The BLA submission includes a comprehensive set of preclinical, clinical and manufacturing data compiled from the Company's completed Phase I/II clinical trial of pegunigalsidase alfa, including the related extension study succeeding the Phase I/II clinical trial, interim clinical data from the Phase III BRIDGE switch-over study and safety data from the Company's on-going clinical studies of PRX-102.

Upon the BLA approval, if approved, the company will be eligible to receive a milestone payment from Chiesi.

Fabry disease is an X-linked inherited disease that results from deficient activity of the lysosomal a-Galactosidase-A enzyme resulting in progressive accumulation of abnormal deposits of a fatty substance called globotriaosylceramide (Gb3) in blood vessel walls throughout a person's body.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
United Airlines has rolled out an interactive online "Map Search" feature for its customers in collaboration with search giant Google. The new feature is powered by Google Flight Search Enterprise Technology. United is claimed to be the first airline in the U.S. to add this feature. The new feature, available on United.com, allows customers to easily search, compare and purchase flight tickets. GHSW, LLC. is recalling Trader Joe's Southwest Style Sweet Potato Sauté Bowl citing undeclared milk and egg allergens in the dressing, according to the Food and Drug Administration. The recall was initiated after it was discovered that the dressing in the bowl contains milk and egg, but are not declared on the label. California Gov. Gavin Newsom signed an executive order on Wednesday that bans the sale of new gasoline-powered vehicles in the state by 2035. With this, California plans to phase out the sale of all gasoline-powered vehicles and to drastically reduce demand for fossil fuel in its fight against climate change. The order directs the California Air Resources Board to develop a plan.
RELATED NEWS
Follow RTT