Multiple sclerosis (MS) patients in Europe could have access to two more orally-active drugs after Biogen Idec’s Tecfidera and Sanofi’s Aubagio were recommended for approval.
The Committee for Medicinal Products for Human Use (CHMP), an expert committee of the European Medicines Agency (EMA), issued positive opinions for both drugs as first-line treatments for adults with relapsing-remitting forms of MS.
Approval would mean that Tecfidera (dimethyl fumarate) and Aubagio (teriflunomide) will join Novartis’ Gilenya (fingolimod) on the EU market. Sanofi’s drug is already available in the US, while Biogen Idec is now awaiting a verdict on Tecfidera (formerly known as BG-12) after the FDA extended its review period by three months.
Tecfidera was recommended for approval on the back of the DEFINE and CONFIRM studies, which showed that a twice-daily dose of the drug reduced the annualised relapse rate of MS patients by 44-49 per cent, whilst reducing disability progression by 34-48 per cent compared to placebo after two years’ treatment.
Meanwhile, studies of Aubagio, including the TEMSO trial, found that once-daily treatment with the drug was associated with a relapse rate around 30 per cent better than placebo over two years, with the higher of two doses tested (7mg and 14mg) also reducing disability progression.
Aubagio setback
There was some disappointing news for Sanofi however as the CHMP did not recommend that teriflunomide receive a new active substance (NAS) designation, meaning that the panel considers it a derivative of an older compound (leflunomide) and not a new drug.
Aside from intellectual property considerations – one analyst has suggested generics could be on the market in three years if teriflunomide is denied NAS status – the decision could have an impact on pricing negotiations and potentially encourage off-label use of leflunomide in MS.
Sanofi said it is “considering all options” and plans to “request a re-examination” of the CHMP’s NAS decision. The verdict is somewhat counterintuitive given that Tecfidera is also similar to an older drug called Fumaderm (fumaric acid esters) that is sold as a psoriasis treatment.
Gilenya was the first oral drug to be approved for MS, offering an alternative to injectable therapy with beta interferon and monoclonal antibodies such as Biogen’s Tysabri (natalizumab).
Gilenya has already made significant headway in the MS market, racking up sales of $494m in 2011 and $1.2bn last year.
Of the oral rivals, Tecfidera is tipped to be the biggest seller by Decision Resources – with sales of $3bn a year by 2017 predicted – followed by Gilenya with revenues of $2bn at peak. Aubagio will be a “modest” product as its clinical profile is less impressive, according to market research firm.