FDA Requires Additional Information From Protalix About Gaucher Disease Drug

The FDA requires more information from Protalix and new Gaucher disease drug

The Food and Drug Administration required additional information about Protalix BioTherapeutics Inc. and their new drug.

The new drug was formulated to treat Gaucher disease, and the FDA would like to have more data about the benefits of it.

Gaucher disease, a rare genetic disorder, is caused by a lack of glucocerebrosidase, a specific enzyme. The disease can cause a variety of symptoms, ranging from cognitive dysfunction to fractures and bone pain.

Protalix has been working to receive an approval from the FDA to market taliglucerase alfa as an effective treatment method for Gaucher disease.

Pfizer Inc. has endorsed Protalix, explaining support and willingness to help produce and market the drug.

The FDA required additional information about how the drug was produced and the chemical makeup of the drug.

Not required by the FDA were additional studies on the drug, but one study is currently taking place on the drug.