EMA accepts Genzyme MS drug for review
pharmafile | February 24, 2012 | News story | Research and Development, Sales and Marketing | EMA, Genzyme, Sanofi, teriflunomide
The European Medicines Agency has accepted Genzyme’s application for its multiple sclerosis pill teriflunomide.
Genzyme, which is wholly owned by Sanofi, is seeking a licence for the drug to treat relapsing forms of multiple sclerosis.
Teriflunomide, which will be branded as Aubagio, is a once-daily pill and works by blocking the proliferation and functioning of activated T and B lymphocytes, which are thought to be especially damaging in MS.
Teriflunomide is already under review by the FDA, and the regulator is set to make a decision on the drug later this year. The drug is expected to make around $500 million in peak annual sales.
Bill Sibold, senior VP and head of multiple sclerosis at Genzyme, said: “The filing represents another important milestone for teriflunomide and brings us one step closer to offering a new treatment option to patients with relapsing MS.
“As an oral therapy with a promising clinical profile, teriflunomide is extremely well positioned to provide an alternative therapeutic option to patients who are currently taking injectable therapies.”
Sibold added that these injectable therapies make up approximately 80% of the MS market today, and include Biogen’s Avonex and Merck Serono’s Rebif.
The application is based on the TEMSO and TENERE Phase III trials. Data from the TEMSO study showed that teriflunomide significantly reduced annualised relapse rates by 31% versus placebo, reaching its primary endpoint.
The risk of disability progression (sustained for 12 weeks) was also significantly reduced by 30% for the high 14mg dose, but the lower 7mg dose did not reach statistical significance.
But the drug failed to bead Rebif in a head-to-head trial last year, as it was not better at reducing relapse rates.
Genzyme is also developing a second MS pill in Lemtrada (alemtuzumab), which is undergoing Phase III trials for relapsing forms of the disease.
The drug is estimated to bring in between $750 million and $2.5 billion in peak annual sales. The firm expects to file the drug to regulators next year.
Competition
If teriflunomide is approved it will compete with Novartis’ Gilenya, which was the first MS pill to be approved in Europe.
But Gilenya is currently undergoing a safety review by the EMA after seven patients died taking the drug.
The regulator is now assessing whether these deaths were related to use of Gilenya, and will report on its findings in March.
If the drug’s benefits are no longer deemed to outweigh its risks, the EMA could pull the drug from the market, or limit is use. The FDA is conducting similar safety assessments.
Ben Adams
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