Fabrazyme: new treatment recommendations

The FAMHP published in 2009 and 2010 communiqués relating to the supply shortage of Cerezyme and Fabrazyme and measures to take about the treatment of the patients concerned.  New recommendations regarding Fabrazyme are made by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), for the attention of specialised physicians in treating patients with Fabry disease (a disease due to an enzyme deficiency). These physicians are regularly informed of developments and recommendations in this regard.

Communiqués published in July and August 2009 and in February 2010 reported supply shortage of Cerezyme (imiglucerase) and Fabrazyme (agalsidase beta), which began in June 2009 due to the contamination of bioreactors used in the manufacture of these medicines. These problems are not solved yet. A return to normal is expected in the second half of 2011.

Following these supply problems, recommendations were issued (including the reduction of doses in some patients with less risk of worsening their condition, to avoid total breakdown of stock). These recommendations are updated regularly according to changing conditions and monitoring of patients receiving reduced doses of Fabrazyme.
While some patients seem to be doing well on the lower Fabrazyme dose, others show a progression in the sickness.

New guidelines (standard Fabrazyme dose or switch to Replagal (agalsidase alfa)) have been formulated and communicated to the concerned physicians.
The CHMP is closely monitoring the supply problems of Cerezyme and Fabrazyme and measures taken by the firm Genzyme to improve the situation.

The concerned physicians are regularly kept abreast of developments in the problem.

All information on this subject is available on the EMA website.





Last updated on 08/11/2010