As a result of the mid-June Genzyme plant shutdown, which brought a halt to the manufacture of enzyme-replacement treatments Cerezyme and Fabrazyme for Gaucher disease and Fabry disease, respectively, the FDA has approached Protalix to start providing its experimental Gaucher's disease therapy prGCD to patients under an expanded access program.
Protalix is discussing a treatment protocol with regulators to expand use of the therapy, a plant-cell expressed recombinant form of glucocerebrosidase now in a late-stage trial, reports sister publication FierceBiotech.
The shutdown of the Boston-area Genzyme plant is the result of a decontamination effort now underway due to Vesivirus 2117 contamination in a bioreactor. The biotech giant faces extended rationing of the two drugs after deciding to sanitize the entire manufacturing facility rather than just the cell-culture production area.
- here's the FierceBiotech report
- see our coverage of the Genzyme plant closure