- Published: Wednesday March 29 2017 09: 17
The Swiss pharmaceutical group Roche said on Wednesday that the US drug agency approved its new treatment against multiple sclerosis, Ocrevus, marking a breakthrough in the treatment of disease.
The Food and Drug Administration (FDA) approved the drug, also called ocrelizumab for primary or recurrent forms of the disease based on Phase III studies, entitled Opera I and II as well qu'Oratorio Opera, the said Basel in a statement.
These have shown that the new drug was more effective than Rebif, a drug used to treat the disease, since it reduces relapse by almost half in the space of one year and slow progression of disability and significantly reduced brain lesions detected by MRI.
Multiple sclerosis is a chronic disease which affects some 2,3 million people in the world 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.
The Ocrevus is administered intravenously every six months for two doses of 300 mg two weeks apart, to which later added 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 presented in September data on the results of these studies at a medical congress in December but US health officials have extended by three months the review period for this treatment.
Ocrevus had obtained breakthrough therapy status, which accelerates the marketing procedures for medicines for serious diseases for which there are few or no treatment options.
The European Medicines Agency, to which Roche has also submitted an application, is currently studying this treatment.
A 10H03 GMT, the title has appreciated by 0,24 253,80% in Swiss francs, while the SMI index core values of the Swiss site, progressed to 0,17%.
"Ocrevus will become the standard of care for multiple primary progressive MS," felt Jefferies analysts in a note.
This drug may also change treatments for patients with relapsing forms, many more, they said, while recalling that they often have to use several different medications over the course of the disease.
Analysts at Jefferies, sales of the drug could reach 4,2 billion Swiss francs (3,9 billion) in 2025 horizon.