Update on Drugs - March 2009

Ustekinumab
Stelara®
Janssen-Ortho

HPB Canada approved this new cytokine inhibitor in December 2008 for the treatment of moderate-to-severe plaque psoriasis. This biologic was also approved by the European Commission in January 2009 for the treatment of moderate-to-severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systematic therapies including cyclosporin, methotrexate and PUVA.

Photopheresis System
THERAKOS™ CELLEX™
Johnson & Johnson

HPB Canada approved this system in January 2009 for the palliative treatment of skin manifestations of cutaneous T-cell lymphoma that are unresponsive to other forms of treatment.

Calcitriol
Vectical™ Ointment
Galderma Laboratories

The US FDA approved this topical vitamin D3 agent in February 2009 for the treatment of mild-to-moderate plaque psoriasis in adults.

Autologous Collagen Cellular Processing System
Isolagen Therapy™
Isolagen, Inc.

The US FDA received a Biologics License Application for this novel, first-in-class cellular therapy in March 2009 for the treatment of wrinkles/nasolabial folds.

Over the past 7 months, 3 virologically confirmed cases of progressive multifocal leukoencephalopathy (PML) have been reported in psoriasis patients treated with efalizumab (Raptiva®, Merck Serono/Genentech), which is currently approved in Europe, the US, and Canada for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who have failed to respond to or who have contraindication to, or are intolerant to certain other systemic therapies. As a result, in February 2009, the European Medicines Agency (EMEA) recommended the suspension of the marketing authorization for this product, and after review, the EMEA concluded that the benefits of efalizumab no longer outweigh its risks. Also in February 2009, Health Canada concluded that the risks outweighed the benefits of this T-cell modulator and suspended its availability in Canada. The US FDA also issued a public health advisory for this drug and is reviewing the reports. The FDA says it will take appropriate steps to ensure that the risks do not outweigh the benefits, and that patients who are prescribed this drug are clearly informed of PML’s signs and symptoms. Health care professionals should carefully monitor for any signs of PML in patients who are taking efalizumab or have discontinued therapy. Physicians in these areas are advised to review the treatment of patients currently receiving this medicine and assess the most appropriate alternative.

In February 2009, the EMEA reviewed the available information on cases of status epilepticus with myoclonus reported in 2 girls vaccinated with the cervical cancer vaccine Gardasil®. Based on the current data, the Agency’s Committee for Medicinal Products for Human Use has concluded that the cases are unlikely to be related to the vaccination and that the benefits of this vaccine continue to outweigh its risk. Therefore, the Committee is recommending that vaccination with Gardasil® should continue in accordance with national vaccination programs in Member States.