Genzyme Corp. is looking for the FDA approval for its cancer drug Mozobil. The drug is expected to be announced in the market very soon. In a phase III trial, the combination of Mozobil and Amgen Inc.’s (AMGN) Neupogen was found to be better than Neupogen alone to mobilize and collect the optimal number of stem cells for bone-marrow transplants.
On December 10, the FDA Orthopaedic and Rehabilitation Devices Panel voted 5-0 to recommend approving the premarket approval application for Synvisc-One.Synvisc-One is a proposed single-shot version of Genzyme’s Synvisc, an FDA- approved therapy of treating osteoarthritis of the knee. Synvisc was approved in the United States in 1997 and has been in use worldwide for more than 16 years.
Synvisc-One is administered through a single intra-articular injection, whereas Synvisc is administered as a series of three injections. If approved, Synvisc-One would be the only single-injection viscosupplement available in the United States. Synvisc-One was approved in the European Union and a number of Asian and Latin American countries last year. Nearly 10,000 patients have been treated with Synvisc-One since its first approval.
The results were based on a double-blind, placebo-controlled trial, which enrolled 298 patients who were undergoing a hematopoietic stem cell transplant for non-Hodgkin’s lymphoma. Genzyme expects Mozobil to be approved in Europe during the first half of next year. Genzyme expects peak sales of Mozobil in the transplant setting to reach $400 million annually.Over the next several quarters, Genzyme anticipates a number of potential approvals for new products or broader indications for existing products.
Last month, the company filed its application with the FDA, seeking expanded approval for Clolar or clofarabine to treat adult patients with acute myeloid leukemia or AML. Clolar is currently approved in the United States and Europe for the treatment of acute lymphoblastic leukemia or ALL in relapsed and refractory pediatric patients one to 21 years old who have received at least two prior treatments.
On November 4, Genzyme inked a $1.38 billion deal with Osiris Therapeutics (OSIR) to commercialize and develop two late-stage adult stem cell treatments — Prochymal and Chondrogen, in a variety of diseases.
Source: RTT News