Shire Completes NDA for Gaucher's Disease Treatment

 
Shire plc (Cambridge, MA) has completed its submission of a new drug application (NDA) for velaglucerase alfa, its enzyme replacement therapy in development for the treatment of Type 1 Gaucher disease, with the US Food and Drug Administration.
 
Earlier this year, the company said it would complete the submission by the end of September. The submission was initiated on July 30, after velaglucerase alfa received fast-track designation from the FDA. Shire has now completed the submission a month earlier than the company predicted. According to Shire’s press release, the company is also on-track to submit European filing for velaglucerase alfa by the end of 2009.
 
Last month, Protalix BioTherapeutics also received fast-track designation from the FDA for prGCD, a development drug for Gaucher’s disease. The fast-track designation is the latest step to help Gaucher’s patients in the wake of the current shortage of Cerezyme, the only drug currently approved for the disease. The Cerezyme shortage occurred because of the drug’s manufacturer Genzyme’s Allston Landing plant closure in mid-June.
 
Previous coverage:
 
Protalix Receives Fast Track Designation for Gaucher's Drug
 
Gaucher Patients Can Be Treated with Protalix's Drug During Cerezyme Shortage
 
Protalix's Gaucher Drug May Fill Gap Left from Genzyme Plant Closure
 
Genzyme Detects Virus Contamination of Bioreactor, Halts Production
 
Shire’s press release