The European Commission has recently granted approval to Bristol Myers Squibb (BMS) for their multiple sclerosis (MS) treatment, Zeposia. It has already been approved by the FDA in the US for patients with relapsing remitting MS that is currently active, and BMS is excited that their treatment will be able to help more people throughout the world.
About Multiple Sclerosis
Multiple sclerosis (MS) is a neurological disorder that affects the sending of signals from the brain to the body. When one has this disorder, their immune systems attack myelin, which is the protective covering of nerve cells. In severe cases, these nerves can be damaged permanently.
There are two types of MS, relapsing/remitting or progressive. The former is characterized by long periods without symptoms followed by episodes of intense symptoms. Progressive MS does not include periods without symptoms, instead people with this type constantly feel the effects of the disorder. It can result in the loss of daily function. It is difficult to know the number of people who are affected by MS, as many often go without a diagnosis or are misdiagnosed. It is thought that 2.3 million people have this disorder worldwide, with 400,000 of those people living in the United States.
There is no known cause for MS. It is an autoimmune disease, which occurs when the immune system attacks parts of the body, in this case myelin. These attacks result in the slowing or blockage of neuro messages. It is suspected that there is a hereditary element, but a combination of genetics and environmental factors are most likely the cause. What is known is that this disorder can occur at any age, but is most common from the ages of 15 to 60, and women are twice as likely to have it.
Symptoms of multiple sclerosis can vary from patient to patient; all parts of the body can be affected. Muscles in the extremities and the eyes are most commonly affected. The first symptoms often appear between the ages of 20 to 40, which could be weakness, numbness, loss of coordination and balance, or problems with speech, vision, and bladder control. While there is currently no cure for MS, specific symptoms can be treated.
Zeposia is a sphingosine 1-phosphate (S1P) receptor modulator, intended to bind to S1P receptors one and five. It lowers the amount of lymphocytes in the blood by blocking them from leaving the lymph nodes. It is administered orally.
Not only do researchers believe that Zeposia is an effective treatment for MS, but they think that it could be indicated for other immune-inflammatory conditions. The next step is to study its effect on ulcerative colitis and Crohn’s disease.
The European Commission has approved this treatment after its performance in two phase 3 trials: SUNBEAM and RADIANCE. More than 2,600 patients were enrolled across 150 sites in 20 countries for these randomized, active-controlled trials. Both compared Zeposia to a drug that has already been approved and used in MS treatment: AVONEX. In terms of relapse and brain lesions, Zeposia was shown to be more effective.
Key findings include:
- In the RADIANCE study, Zeposia reduced T1-weighted GdE brain lesions by 53%, while also reducing new T2 lesions by 42%. Both of these numbers were higher than those treated with AVONEX.
- The SUNBEAM trial showed similar results, with reductions in both of those brain lesions. 63% reduction in T1-weighted GdE lesions, and 48% decrease in T2 lesions, again more effective than AVONEX.
- The SUNBEAM study resulted in a 48% relative reduction in annualized relapse rate (ARR), more effective than AVONEX.
- The RADIANCE study resulted in a relative reduction in ARR of 38%.
- A reduction in whole brain volume from baseline was larger in those treated with Zeposia.
Beyond these results, Zeposia was safe and well tolerated. While researchers acknowledge that there is no “one-size fits all” approach to treatment for MS, they are very excited by these results and the good they can do for MS patients across the world.
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