Lettre de Genzyme du 3/08/09 aux US malades : révision du programme de gestion du stock

Vous trouverez des articles traitant du même sujet dans la catégorie "A propos des traitements et prise en charge".

Liens utiles à la fin des catégories.
Ghislaine SURREL

maladies-lysosomales-subscribe@yahoogroupes.fr

Genzyme Corporation

500 Kendall Street Cambridge, MA 02142

Tel 617-252-7500

August 4, 2009

 RE: Revised Cerezyme® (imiglucerase for injection) Supply Management plan effective August 3, 2009

Dear Patient: 

I am writing to you today to provide an important update on the period of temporary shortage of Cerezyme. We continue to work diligently to restore production at our Allston facility and to responsibly manage the supply of Cerezyme with the goal of protecting the most vulnerable patients. We realize that this situation presents very real challenges for patients, their families, and their physicians during this time.

We are so grateful for the many efforts made by members of the Gaucher community to conserve supply either by missing or reducing doses, as those efforts have helped with supply conservation. However, although many physicians and patients have communicated their intent to alter their treatment regimens there has not yet been a significant reduction in the amount of Cerezyme orders and shipments. Currently, our levels of inventory of Cerezyme on hand are at a point that we are at risk of not maintaining enough product to enable the most vulnerable patients to continue receiving their regular doses through the entire period of supply constraint. 

On Friday, July 31, the Cerezyme Stakeholders Working Group (composed of patient advocacy leaders, and fourteen U.S. physicians) met to review the current situation and as well as a revised supply management plan for the month of August.

In order to preserve inventory for the most vulnerable patients, effective immediately we will only ship Cerezyme for Gaucher patients who fall into the following three groups: children 18 years of age and younger, patients with neuronopathic Gaucher (type 2 and type 3), and those patients facing life-threatening clinical situations.  A Cerezyme Emergency Access Program (CEAP) has been established to allow patients and physicians to apply for emergency access in the case of life-threatening need. The Cerezyme Stakeholders Working Group will reassess inventories at the end of August 2009 and help to determine the best way forward.  

Please speak with your doctor about this updated plan and for more information.  Should you have questions, you may also call your Genzyme Case Manager or Genzyme Medical Information at 1-800-745-4447.  A copy of the Cerezyme US Prescribing Information is included with this letter.  This information does not take the place of talking to your doctor about your condition or your treatment.

Please be assured that Genzyme is resolute in our commitment to patients, and continues to work to support Gaucher families in the US and around the world  We are steadfast in our determination to work collaboratively with the FDA, the Gaucher patient community, and physicians to best manage these challenges.

Sincerely,

C. Geoffrey McDonough, MD

Senior Vice President, General Manager

Lysosomal Storage Disorders Therapeutics    

CZ-US-P073-08-09