In brief: European Medicines Agency news
pharmafile | January 26, 2010 | News story | Research and Development, Sales and Marketing | Arepanrix, Arzerra, EMEA, GSK, Tysabri
GlaxoSmithKline’s influenza vaccine Arepanrix has been granted conditional marketing authorisation in Europe under an emergency fast-track procedure.
It is the fourth pandemic flu jab to be approved by the European Medicines Agency’s CHMP committee.
Arepanrix (split virion, inactivated, AS03 adjuvanted influenza H1N1 pandemic vaccine) was recommended after a rolling review of available data started last July.
Results of more clinical studies in children, adolescents and adults will be available from March.
GSK’s Arzerra (ofatumumab), approved in the US last October, has also been given the European green light as a second line treatment for patients with chronic lymphocytic leukaemia (CLL).
The monoclonal antibody, which targets the CD20 protein found on the surface of B lymphocytes, can be used in CLL which is refractory to fludarabine and alemtuzumab.
The EMA will review further information on Arzerra, on its long-term use and comparative data on patients ineligible for alemtuzumab, within a year.
Meanwhile the CHMP has also approved BioPartners’ Ribavirin Biopartners (ribavirin), a generic of Rebetol, for the treatment of hepatitis C in combination with peginterferon alfa-2b or interferon alfa-2b.
The Committee has also adopted its first opinion on compassionate use, which means an intravenous formulation of Roche’s Tamiflu can treat critically ill patients with a life-threatening condition due to pandemic or seasonal flu.
It has also decided, following a review, that the benefits of Elan’s Tysabri (natalizumab) continue to outweigh risks to patients with highly active relapsing-remitting multiple sclerosis.
It said the risk of developing progressive multifocal leukoencephalopathy (PML), a rare brain disease caused by the JC virus, increases after two years.
But these MS sufferers, for whom there are few treatment options available, should continue to take it, the review said.
However, the CHMP recommended an update of the product information to reflect the increase in risk after two years, plus advice on how to manage patients who show signs of PML.
It also said forms should be signed by patients at the beginning of Tysabri treatment and again after two years, after risk discussions with their doctor.
In another review the Committee recommended the suspension of marketing authorisation for sibutramine-containing medicines on the basis their weight-loss benefits did not outweigh cardiovascular risks.
This means doctors have been told not to prescribe the Abbott treatment, marketed in Europe under names including Reductil, Reduxade and Zelium.
The CHMP also recommended harmonising the packaging of AstraZeneca’s stomach acid treatment Losec (omeprazole) and began a review of non-steroidal anti-inflammatory drug bufexamac over concerns about allergic reactions.
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