OXFORD, England, Nov. 21 /PRNewswire-FirstCall/ -- Oxford GlycoSciences Plc (Nasdaq: OGSI: LSE: OGS) today announces that feedback has been received from the U.S. Food and Drug Administration (FDA) about the End-of-Review Conference on Zavesca. The FDA said it believes that management of benefit/risk ratio can be achieved through restricted use of the drug.
OGS' Chief Medical Officer, Chris Moyses, said, "We are pleased that the FDA has opened the way for an NDA amendment." He added, "While the letter was not specific about the data required by the FDA to demonstrate safety and efficacy in the intended indication, additional information will be provided from studies that have continued since the original NDA was submitted."
On the basis of this feedback, it is intended to submit an amendment to the NDA for Zavesca early next year.
Notes to Editors
Zavesca regulatory background
OGS submitted an NDA for Zavesca for the treatment of patients with type 1 Gaucher disease in August 2001. In June 2002, the FDA issued a complete response letter indicating that the product was not approvable based on the FDA's opinion that OGS had not provided sufficient support of safety and efficacy of the drug. In accordance with FDA procedure, OGS requested and received a hearing on whether there were grounds for denying approval of the application. The FDA letter to OGS was a follow-up to this meeting.
Gaucher disease
Gaucher disease is a rare genetic disorder, which results from reduced activity of glucocerebrosidase, an enzyme responsible for glycosphingolipid (GSL - a subclass of fats) metabolism. Symptoms include enlargement of spleen and liver, bone disease and anaemia.
Treating Gaucher disease with Zavesca
Zavesca is an oral inhibitor of glucosylceramide synthase, a key enzyme involved in GSL biosynthesis. The rationale for the use of Zavesca is to help balance the overall level of GSLs by inhibiting their production or synthesis -- termed 'substrate reduction'.... |
