Aubagio approved in Europe
pharmafile | September 3, 2013 | News story | Sales and Marketing | Aubagio, Genzyme, Rebif, Sanofi, tecfidera
Sanofi’s once-daily multiple sclerosis pill Aubagio has been authorised by European regulators, paving the way for it to continue its battle against the older injections which remain a key part of the market.
The European Commission says Aubagio (teriflunomide) 14 mg can be used to treat adults with relapsing remitting MS.
The immunomodulator, made by Sanofi’s subsidiary Genzyme, has already been launched in the US but faces stiff competition from Biogen Idec’s own pill Tecfidera (dimethyl fumarate), which has been recommended in the EU and approved by the FDA.
Tecfidera is the only known drug to have demonstrated activation of the Nrf-2 pathway, which provides a way for cells to defend themselves against the inflammation caused by the chronic, disabling disease.
Injectable therapies such as Biogen’s existing Avonex and Merck Serono’s Rebif still make up the majority of the MS market but this is changing.
Other competitors in tablet form include Novartis’ Gilenya (fingolimod) – the first once-daily tablet approved to treat relapsing forms of MS – with two large Phase III studies suggesting Gilenya has a positive effect on relapses and MRI outcomes if used early.
For its part, Aubagio significantly reduced relapse rate and time to disability progression at two years versus placebo in the Phase III TEMSO and TOWER trials – and EC approval was based on these.
“Aubagio’s efficacy, safety and convenient dosing may provide an attractive treatment option for patients,” said Genzyme president David Meeker.
How Aubagio works is not fully understood, but it might involve a reduction in the number of activated lymphocytes in the central nervous system (CNS) – MS attacks the CNS, leading at its worst to paralysis or loss of vision.
The drug is also approved in Australia, Argentina, Chile and South Korea, and is under review elsewhere. MS is estimated to affect more than 2.1 million people globally, around 630,000 of whom are in Europe.
Adam Hill
Related Content
Sanofi and Regeneron’s Dupixent receives CHMP recommendation for chronic spontaneous urticaria
Sanofi and Regeneron have received a positive opinion from the European Medicines Agency’s (EMA) Committee …
Sanofi’s treatment granted orphan designation for rare chronic inflammatory condition
The European Medicines Agency has granted orphan designation to Sanofi’s investigational Bruton’s tyrosine kinase (BTK) …
Sanofi completes acquisition of Vigil Neuroscience to early neurology pipeline
Sanofi has announced that it has finalised its acquisition of Vigil Neuroscience, a US-based biotechnology …
