As Genzyme previously stated in July 2008 and again in October 2008, due to greater than expected adoption and rapidly increasing global demand, Myozyme (2000 L) supply will be particularly tight until 4000 L production is approved in the European Union. Beginning in January inventory levels are expected to be so tight that there is a risk of delays in order fulfillment that could result in potential interruptions to therapy. To responsibly manage through this temporary supply constraint and best support those currently receiving Myozyme produced at the 2000 L scale, and in particular to safeguard supply for infants and children worldwide, the company has taken a number of steps to ensure optimal management of the existing supply until the 4000 L manufacturing scale is approved by the European Medicines Evaluation Agency (EMEA). Genzyme will continue to work collaboratively with the EMEA to expedite the review of the 4000 L process. Also, Genzyme is exploring the potential for providing Pompe patients with access to Myozyme produced at the 4000 L scale prior to approval in the European Union, should this become necessary.
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