Tysabri is now available as SC in Europe
Biogen announced that the European Commission had approved the new subcutaneous form of Tysabri (natalizumab). The drug is indicated for treating relapsing-remitting multiple sclerosis. The drug has the same efficacy and safety as Tysabri intravenous formulation.
The approval is based on the DELIVER and REFINE studies, which demonstrated the subcutaneous route administration has comparable efficacy to the Q4W IV administration.
Biogen announced that Tysabri is the first product indicated for multiple sclerosis that is approved under two dosage forms.
Tysabri is marketed by Biogen, indicated for relapsing multiple sclerosis, helps to slow down physical disability progression, decreasing the new brain lesions formation and cut relapses. The drug is approved in 80 countries, 213,000 patients were treated with Tysabri worldwide.