08-Dec-2009

Fabrazyme Short Supply for Fabry Patients in 2010

TEMPORARY SHORTAGE OF FABRAZYME

As many of you are aware by now, there has been a disruption in the supply of the Genzyme Fabry treatment product Fabrazyme.  Genzyme detected a virus that impairs cell growth in one of six bioreactors at its Allston Landing manufacturing facility in the U.S. The company has decided to temporarily interrupt bulk production at the plant to sanitise the facility.   The interruption of manufacturing at the Allston facility will result in a temporary shortage in the supply of Fabrazyme.

To help address this situation, Genzyme Australasia has been working with the Life Saving Drugs Program (LSDP) and Therapeutic Goods Administration (TGA) to ensure appropriate management of Fabrazyme supply during this temporary period of shortage.

The Australian Government have indicated that they will be implementing this strategy immediately and widely in an effort to avoid a complete depletion of Fabrazyme supply during the period of Fabrazyme shortage.

The Fabry Patient Advisory Committee and LSDP have proposed the following rationing strategies beginning 1st August.

• Patients may remain on their current choice of drug.
• Patients who have been on Fabrazyme for less than 12 months will have their dose maintained at 1mg/kg for a full twelve months, if possible
• Other Fabrazyme patients will have their doses reduced to 0.5mg/kg for males and 0.3mg/kg for women

Genzyme asked me to forward the following websites to FSGA members who receive Fabrazyme ERT:

www.genzyme.com and www.genzyme.com/supplyupdate are live and are updated with information regarding the Allston Landing manufacturing facility.  

The site is intended as a vehicle to share Genzyme’s most up to date information with their stakeholders in a timely and forthright manner. It will be updated with public information, and it is recommended that you log in your email address so that you receive updates as the site posts new information. 

Please be aware that if no changes are made in current Fabrazyme use, available supply will not be sufficient to meet global demand during this temporary period of supply constraint. By taking action now and participating as a community in the supply management effort, we can all help to reduce disruptions to therapy.

If patients have any medical concerns at all Fabry Support Group Australia encourages patients to speak to their Fabry treating Doctor.

Letters to FSGA Members

Fabry Support Group Australia Inc have been kept informed about the Fabrazyme shortages and contaminations from the Life Saving Drugs Program (LSDP) and Genzyme Australasia.  Please find below the information that FSGA have circulated to its members over the past 6 months.

JULY 2009
In July a letter was distributed to FSGA members regarding Fabrazyme shortages

SEPTEMBER 2009
In September a letter was distributed to FSGA members regarding Fabrazyme shortages

OCTOBER 2009
In October a letter ‘Dear Fabry Community Member’ was distributed to FSGA members via FIN.

NOVEMBER 2009
In November the Life Saving Drugs Program distributed the following letter to Fabrazyme Stakeholders:

NOVEMBER 2009
On November 28 Genzyme sent information to be distributed via FSGA Newsletter about foreign particles in Fabrazyme products.

DECEMBER 2009
In December FSGA received a letter from Genzyme with regard to supply of Fabrazyme to patients for first quarter of 2010.