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FDA approves first drug to treat severe MS after 40 years


After 40 YEARS of research – the FDA approves first drug to treat severe form of multiple sclerosis

  • The FDA has approved the first drug ever to treat the most severe form of MS
  • The disease disrupts the flow of information within the brain, and between the brain and body, and patients can end up permanently disables
  • Until recently, sufferers had to manage symptoms as past drugs had failed

After 40 years of research, the FDA has finally approved a drug to treat the most severe form of multiple sclerosis.

The IV infusion, known as Ocrevus, will be used to treat the primary progressive form of the neurological disease, known as PPMS.

Multiple sclerosis (MS) is when the flow of information within the brain, and between the brain and body, is disrupted – and patients can end up permanently disabled.

Until recently, those suffering from PPMS were often relegated to managing symptoms and working with rehabilitation specialists because past drugs had failed to make a difference.

The drug, also known as ocrelizumab, is administered via IV infusion.

Ocrevus works by reducing the immune system’s assault on the body’s own neurons. Unlike some other MS drugs that target T cells, it tackles B cells’ role in driving inflammation that is central to the neurological disease.In trials with the drug, however, doctors found no evidence of disease progression in 47 percent more PPMS patients compared with a placebo.

Approximately 400,000 people have multiple sclerosis in the US, according to the MS Foundation, with the 10 to 15 percent suffering from PPMS largely without effective treatment options.

PPMS is characterized by worsening neurologic function, while the more-common relapsing form (RRMS) comes and goes with attacks of new and increasing symptoms.’The FDA’s approval of Ocrevus is the beginning of a new era for the MS community and represents a significant scientific advance,’ said Sandra Horning, chief medical officer of Roche, the maker of the drug.

Ocrevus will have a list price of $65,000 per year, undercutting rival Merck’s Rebif by a quarter.

Among RRMS patients, Roche claimed 75 percent more patients reached ‘no evidence of disease activity’ status when taking Ocrevus compared with those using Rebif.’This is a real game changer,’ said Cyndi Zagieboylo, president of the National MS Society.While the FDA approval was largely expected, analysts say the FDA’s broad support, for both forms of the disease, was a plus.

‘The label is close to the best case,’ wrote Emmanuel Papadakis, a Barclays analyst, adding Ocrevus does not include health warnings accompanying other MS drugs such as Biogen’s Tysabri and Sanofi’s Lemtrada.

Analysts forecast annual sales exceeding $3 billion by 2021, according to Reuters data.The drug’s US entry had been delayed by three months when the FDA pushed back its approval deadline in December, citing manufacturing concerns.

Roche rival Novartis AG is also developing an MS treatment, BAF312, for secondary progressive multiple sclerosis. It could file for regulatory approval later this year, Novartis has said, although the official target remains 2019.Multiple sclerosis (MS) is a disease of the central nervous system, which includes the brain, spinal cord and optic nerves.

The flow of information within the brain, and between the brain and body, is disrupted.

Patients can end up permanently disabled from the disease.

About 400,00 people in the US have MS and women are twice as likely to have it as men.

Signs and symptoms:

There is currently no cure for MS. However, medications can help ease attacks and possibly slow the disease’s progress.Physical therapy and other treatments can help control symptoms and may improve quality of life.

There are four types of MS:

1. Relapsing-remitting multiple sclerosis

Most people with RRMS have this type, which usually starts in your 20s and 30s.If you have RRMS, you may have attacks when your symptoms flare up. These are called relapses.

2. Secondary progressive multiple sclerosis

People with SPMS start out with another type of MS – RRMS.

Most people with relapsing-remitting MS, about 80 percent, eventually get SPMS.

The relapses and remissions that used to come and go change into symptoms that steadily get worse.

2. Progressive relapsing multiple sclerosis

If you have PRMS, you’ll have distinct attacks of symptoms, called relapses. You may or may not fully recover after these flares.

Between relapses, the disease continues to slowly get worse.

3. Primary progressive multiple sclerosis

Between 10 and 15 percent of people with MS have PPMS – the most debilitating form.

Once it starts, PPMS gets worse over time. Unlike some other types of MS, there are no relapses or remissions.

The FDA has approved the first drug, after 40 years of research, to treat the most severe form of multiple sclerosis. MS is a disruption of the flow of information within the brain, and between the brain and body, that can permanently disable sufferers b-error

Source: http://www.dailymail.co.ukhttp://www.dailymail.co.uk/health/article-4360674/U-S-approves-Roche-drug-targets-severe-form-MS.html