The Swiss pharmaceutical group Roche announced Wednesday that the US drug agency has approved its new treatment for multiple sclerosis, Ocrevus, marking a breakthrough in the treatment of the disease.
The Food and Drug Administration (FDA) has approved this drug, also known as ocrelizumab, for primary or recurrent forms of the disease based on Phase III studies, entitled Opera I and Opera II as well as Oratorio, indicated Basel group in a statement.
They have shown that this new drug is more effective than Rebif, one of the drugs used to treat the disease, as it reduces relapses by almost half within one year and slows down disability progression and significantly reduce the brain lesions detected by MRI.
Multiple sclerosis is a chronic disease that affects some 2,3 million people worldwide but for which there is no cure.
The disease occurs when the immune system mistakenly attacks part of the central nervous system such as brain, spinal cord and the optic nerves.
It occurs usually between 20 and 40 years and results in many symptoms such as fatigue, muscle weakness and vision problems, and can lead to disability.
Ocrevus is administered intravenously every six months in two doses of 300 mg at two-week intervals, plus a dose of 600 mg.
The most common side effects in clinical trials were infusion reactions and infections of the upper respiratory tract, usually mild to moderate, said the Swiss group in the statement.
Roche submitted data on the results of these studies at a medical congress in September, but in December the US health authorities extended the review period for this treatment by three months.
Ocrevus has achieved therapeutic breakthrough status, which speeds up the marketing procedures for drugs for serious diseases for which there are few or no treatment options.
The European Medicines Agency, to which Roche has also lodged an application, is currently studying this treatment.
At 10H03 GMT, the stock was up from 0,24% to 253,80 Swiss francs while the SMI, the index of flagship values of the Swiss market, rose by 0,17%.
"Ocrevus will become the standard of care for primary progressive multiple sclerosis," said Jefferies analysts in a note.
The drug could also change treatments for patients with recurrent forms, many more, they added, while recalling that they often have to use several different drugs as the course of the disease.
According to Jefferies analysts, sales of this drug could reach 4,2 billion Swiss francs (3,9 billion) on the 2025 horizon.