Two Existing MS Drugs, One New One Demonstrate Efficacy in Trials
Long-term efficacy data on two multiple sclerosis drugs — Novartis’ Gilenya and Sanofi’s Lemtrada — back their ability to keep relapsing MS at bay, while Roche’s investigational ocrelizumab performed well in both relapsing and primary progressive forms of the disease.
In two Phase III trials, patients taking Gilenya (fingolimod) had no relapses, MRI lesions, MS-related brain shrinkage or disability progression over seven years.
Similarly, data released by Sanofi and its Genzyme subsidiary shows 64 percent of patients treated for one year with Lemtrada (alemtuzumab) did not require additional dosing in the following four years, and 78 percent did not have worsening of disease.
The data was presented this week at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona, Spain. The FDA approved Gilenya in 2010 and Lemtrada last November.
Meanwhile, Roche says three Phase 3 trials of ocrelizumab showed it reduced markers of relapsing MS compared with interferon beta-1a over a two-year period. In patients with primary progressive MS, the drug significantly reduced the progression of clinical disability and sustained it for at least 12 weeks — the primary endpoint — and 24 weeks — the secondary endpoint — compared with placebo.
Roche said it plans to pursue regulatory approvals for ocrelizumab for both indications in early 2016.
In a new report, GlobalData predicts moderate growth of 1.5 percent a year in the worldwide MS market to $20 billion in 2024. The launch of new oral formulations of MS drugs, along with ocrelizumab and other drugs that target progressive forms of the disease, will affect the market.
Barriers to growth include patent expiration of branded products, which will allow generics into the market, the report notes. Gilenya is facing generic competition from Torrent, Apotex and Mylan after the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board invalidated one of the drug’s patents in September. — Kellen Owings