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FDA Gives Thumbs Up To Multiple Sclerosis Drug From Novartis

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On March 26, the Food and Drug Administration announced that it has approved a Novartis drug called Mayzent (siponimod).

This medication aims to control the worsening conditions of relapsing forms of MS. These include clinically isolated syndrome, active secondary progressive disease, and relapsing-remitting MS.

MS is an autoimmune disease affecting the nervous system. The body's immunity destroys myelin, which acts as a protection for the nerves. In the process, they undergo damage and scarring.

Treatment for MS Progression

These changes prevent the brain to communicate with the different parts of the body. While the signs can vary, symptomatic individuals may experience trouble walking, loss of balance, poor vision, or incontinence.

MS can also manifest in different ways. Most will go through relapsing-remitting period. It is characterized by episodes of worsening conditions and then remission. Some, however, may have worsening symptoms and persistent disability regardless of relapses, a condition known as SPMS.

More than 70 percent of people with RRMS will eventually progress to SPMS, and Mayzent may be beneficial to these individuals.

"With Mayzent, SPMS patients with active disease will have access to the first effective oral therapy directed towards disease progression, even when MS transitions to a stage where deterioration is less dependent on the usual relapse activity," said Paul Hudson, the company's CEO.

The Basis Of The Approval

The drug's approval was based on the results of Phase III of EXPAND clinical trial. It was a randomized, double-blind study that compared the safety and efficacy of siponimod against a placebo.

More than 1,000 adults with SPMS participated of which 545 received the placebo. They took the medication for 37 months with periodic assessments of their disability.

The findings revealed that within three months, 26 percent of those who received siponimod experienced disease progression. About 30 percent who took the placebo experienced the same. Taking the drug then reduced the risk by 21 percent.

Beating The Challenges

Novartis hopes to release the drug into the market within the week, but as early as now, it may encounter challenges. One of these is the cost.

The company may sell it for $88,000 a year, which is significantly more expensive than the other MS drugs. It's also an amount that many MS patients may not be able to afford or sustain.

While it doesn't need a first-dose observation, FDO may be essential for those with a preexisting heart condition. It also has side effects such as macular edema. The medication is also not ideal for those with non-active SPMS.

Nevertheless, it can be one step to effectively manage MS, which affects more than 400,000 people in the United States. Another possible treatment for the disease is stem cell therapy.

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