Mental HealthSupply Shortages Of Cerezyme And Fabrazyme - Priority Access Forpatients Most In Need Of Treatment Recommended
The European Medicines Agency"s (EMEA) Committee for Medicinal Products
for Human Use (CHMP) has recommended that patients who are in greatest
need of treatment are given priority access to Cerezyme (imiglucerase)
and Fabrazyme (agalsidase beta) during the expected supply shortage of
these two medicines over the next few months.
Cerezyme and Fabrazyme are both used to treat rare, inherited
enzyme-deficiency disorders. Cerezyme is used in patients with Gaucher
disease, a disease in which patients do not have enough of an enzyme
called alglucerase. Fabrazyme is used in patients with Fabry disease, a
disease in which patients do not have enough of an enzyme called
alpha-galactosidase A.
The supply shortage is caused by the shutting down of Genzyme"s
production site in Allston Landing, in the United States of America,
where both medicines are produced. The company found a viral
contamination (calicivirus of the type Vesivirus 2117) and has shut down
the production facility for a sanitization of the bioreactors. The virus
is not known to cause disease in humans, but it may affect the quantity,
but not the quality, of the enzymes produced in the bioreactors. An
in-depth investigation of the cause of the contamination is ongoing.
While the facility is shut down, no new stocks of Cerezyme and Fabrazyme
can be produced. All batches manufactured prior to the detection of the
contamination were tested and the Agency confirmed that they are
suitable for release. To ensure that existing stocks last as long as
possible until new batches can be produced, the European Medicines
Agency has agreed to some temporary changes to the way these medicines
are prescribed proposed by the company. These changes should be
implemented immediately.
* For Cerezyme, priority is given to infants, children and adolescents,
and adults with active disease progression. These patients can continue
to receive Cerezyme at the standard dosage schedule of one infusion
every two weeks. However, adult patients without clinical evidence of
active disease progression should receive Cerezyme at a reduced dose
(half a dose once every two weeks) or at a reduced infusion frequency
(once a month at their current dose).
* For Fabrazyme, priority is given to children and adolescents, and
adult male patients, who should continue to receive Fabrazyme as one
infusion every two weeks. However, adult female patients, in whom the
disease is less severe, may receive Fabrazyme at a reduced dose.
These are temporary recommendations and do not change the currently
approved Product Information for either Cerezyme or Fabrazyme. It is
expected that these changes will need to continue until the end of the
year.
Notes
1. More information is available in a question-and-answer document.
2. More information on Cerezyme, including the currently approved
Product Information, is available in the
European Public Assessment
Report.
More information on Fabrazyme, including the currently approved Product
Information, is available in the
European Public Assessment Report.
European Medicines Agency