EMEA recommends suspension of the marketing authorisation of Raptiva (efalizumab)

The European Medicines Agency (EMEA)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.

1. More information is available in a question-and-answer document.
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.

Most Popular Now

How SARS-CoV-2 mutates to escape antibody binding

In a recurring pattern of evolution, SARS-CoV-2 evades immune responses by selectively deleting small bits of its genetic sequence, according to new research from the Uni...

Anticancer drug may improve outcome for severe COV…

Treating severe COVID-19 patients with the anticancer drug bevacizumab may reduce mortality and speed up recovery, according to a small clinical study in Italy and China ...

Pfizer and BioNTech commence global clinical trial…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the first participants have been dosed in a global Phase 2/3 study to further evaluate the saf...

GSK and Vir Biotechnology expand coronavirus colla…

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) have signed a binding agreement to expand their existing collaboration to include the resear...

One dose of COVID-19 vaccine provokes strong immun…

Although clinical trial data are encouraging, real-world evidence with regard to the COVID-19 vaccine remains scarce. In particular, response to the vaccine among those p...

Johnson & Johnson announces submission of appl…

Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting E...

Could a nasal spray prevent coronavirus transmissi…

A nasal antiviral created by researchers at Columbia University Vagelos College of Physicians and Surgeons blocked transmission of SARS-CoV-2 in ferrets, suggesting the n...

European Commission purchases additional 150 milli…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission purchased an...

Johnson & Johnson Announces Submission to Worl…

Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization...

Neandertal gene variants both increase and decreas…

Last year, researchers at Karolinska Institutet in Sweden and the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany showed that a major genetic risk ...

CureVac initiates rolling submission with European…

CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today annou...

Pfizer and BioNTech publish data from in vitro stu…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the publication in Nature Medicine of data from in vitro studies that demonstrate that sera from in...