Genzyme To Launch Thyrogen® in Europe
On September 19, the Committee for Proprietary Medicinal Products of the European Medicines Evaluation Agency adopted a positive opinion on a variation to the manufacturing process for Thyrogen, which was necessary for commercial introduction of the product. Thyrogen was approved for marketing in Europe last year and has been available on a named-patient basis since then.
“This action will enable us to make Thyrogen available much more broadly in Europe,” said David Meeker, M.D., senior vice president of therapeutics at Genzyme Corp. “Thyrogen fills a serious clinical need, and we look forward to communicating with physicians about the product’s role in the management of their patients with thyroid cancer.”
Genzyme plans to launch Thyrogen on a country-by-country basis, as pricing and reimbursement approvals are obtained. The product will be sold by Genzyme’s existing specialty therapeutics sales force in Europe and through marketing partners in selected countries.
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