Multiple sclerosis rivals gain EU approval
pharmafile | March 27, 2013 | News story | Research and Development, Sales and Marketing | Biogen IDEC, Genzyme, MS
Rival MS treatments from Biogen Idec and Genzyme have both received European approval.
The CHMP has recommended marketing authorisation for Biogen’s Tecfidera (dimethyl fumarate) as well as for Genzyme’s rival Aubagio (teriflunomide). Both are once-daily oral treatments for adult patients with relapsing-remitting multiple sclerosis (MS).
Biogen’s chief executive George Scangos said: “With the CHMP’s positive opinion for Tecfidera, we are one step closer to offering the European MS community a treatment with compelling efficacy and a favourable safety profile in the convenience of a pill.”
Tecfidera is the only currently known investigational compound for the treatment of relapsing-remitting MS that has experimentally demonstrated activation of the Nrf-2 pathway. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.
The treatment is currently awaiting FDA approval and should it receive this, would follow Novartis’ Gilenya and Sanofi’s Aubagio into the increasing market for MS drugs.
Commenting on Aubagio’s news, David Meeker, Genzyme’s chief executive said: “This positive CHMP opinion and broad recommended indication reflect the strong data from Aubagio’s clinical development programme. As we’ve seen from the uptake of Aubagio in the US, many patients are looking for an alternative to current injectable therapies.”
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exactmechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).
Genzyme was hoping to receive a new active substance designation for the drug, but this was not forthcoming from the CHMP in the ruling which Genzyme said ‘disappointed’ the firm.
Multiple sclerosis is said to affect an estimated 2.5 million people worldwide and is a chronic, often disabling disease that attacks the CNS, which is made up of the brain, spinal cord and optic nerves.
Symptoms may be mild or severe, ranging from numbness in the limbs to paralysis or loss of vision. The progression, severity, and specific symptoms of MS are unpredictable and vary from one person to another.
Meanwhile, Novartis has released new data on its established oral MS treatment, Gilenya. The new data show the drug can consistently decrease brain volume loss, with a significant effect seen as early as six months.
Brett Wells
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