Exhibit
1
PRESS
RELEASE
European
Medicines Agency recommends suspension of the marketing authorisa-
tion of
Raptiva (efalizumab)
The
European Medicines Agency (EMEA) has recommended the suspension of the marketing
authorisation for Raptiva (efalizumab), from Serono. The EMEA’s Committee for
Medicinal Products for Human Use (CHMP) has concluded that the benefits of
Raptiva no longer outweigh its risks, because of safety concerns, including the
occurrence of progressive multifocal leukoencephalopathy (PML) in patients
taking the medicine.
Raptiva
has been authorised in the European Union (EU) since September 2004 to treat
adult patients with moderate to severe chronic plaque psoriasis (a disease
causing red, scaly patches on the skin), who have failed to respond to, or who
have a contraindication to, or are intolerant to other systemic therapies
including ciclosporin, methotrexate and PUVA (psoralen
ultraviolet-A).
The CHMP
reviewed the medicine at the request of the European Commission, following
reports of serious side effects, including three confirmed cases of PML in
patients who had taken Raptiva for more than three years. PML is a rare brain
infection that usually leads to severe disability or death. Two of the three
confirmed cases of PML reported to the CHMP resulted in the patient’s death. The
CHMP also received an additional report of a suspected case of PML, which could
not be confirmed.
Following
review of all available data on the medicine’s safety and effectiveness, the
CHMP concluded that:
-
Raptiva’s benefits are modest;
- in
addition to PML, Raptiva is associated with other serious side effects,
including Guillain-Barré and Miller-Fisher syndromes, encephalitis,
encephalopathy, meningitis, sepsis and opportunistic infections (infections
occurring in people with compromised immune systems);
- there
is not enough evidence to identify a group of patients in which the benefits of
Raptiva outweigh its risks, in particular there is a lack of data on
effectiveness and safety in patients who have no other treatment options and who
may already have a weakened immune system as result of previous
treatments.
The CHMP
was therefore of the opinion that the risks of Raptiva outweigh its benefits and
that the marketing authorisation for this medicine should be suspended in the
EU.
Prescribers
should not issue any new prescriptions for Raptiva and should review the
treatment of patients currently receiving the medicine to assess the most
appropriate alternatives. They should make sure that patients who have been
treated with Raptiva are closely monitored for neurological symptoms and
symptoms of infection. Patients who are currently taking Raptiva should not stop
treatment abruptly, but should make an appointment with their doctor to discuss
the most appropriate replacement treatment.
The
EMEA’s recommendation has been sent to the European Commission for the adoption
of a legally binding decision.
Notes:
1.
|
More
information is available in a question-and-answer document.
(www.emea.europa.eu/humandocs/PDFs/EPAR/raptiva/RaptivaQ&A_1552509en.pdf)
|
2.
|
The
suspension of a marketing authorisation is a temporary measure, during
which time a medicinal product is not available. The lifting of the
suspension is conditional on the marketing authorisation holder being able
to demonstrate a positive benefit-risk balance for certain groups of
patients.
|
3.
|
More
information about Raptiva is available in the European public assessment
report here: http://www.emea.europa.eu/humandocs/Humans/EPAR/raptiva/raptiva.htm
|
4.
|
This
press release, together with other information on the work of the EMEA,
can be found on the EMEA website:
www.emea.europa.eu
|
Media
enquiries only to:
Martin
Harvey Allchurch or Monika Benstetter
Tel.
(44-20) 74 18 84 27, E-mail press@emea.europa.eu