Biogen and AbbVie Wins FDA Approval for an Injectable Drug Used to Treat MS in US

Biogen and AbbVie announced that it finally got the approval of the Food and Drug Administration to market Zinbryta or daclizumab, an injectable drug used to treat Multiple Sclerosis. This self-administered drug is applied through skin injection.  It is used for relapse forms of MS.

Zinbryta is advice for patients who failed two prior therapies.  It comes with a box warning – the most severe warning issue by the Food and Drug Administration because of its potential serious and systemic side effects. The clinical trials showed that this drug can cause various immune system conditions and potential liver injury.

The European regulators also recommended for Zinbryta’s approval last April.

Multiple Sclerosis or MS is a chronic form of autoimmune and inflammatory disease of the central nervous system.  It disrupts the communicating signals coming from the brain to the other parts of the body.

FDA approved the released of this drug because of the statistically significant results from the two clinical trials.

In the first trial, patients were given either Biogens Avonex or Zinbryta.  The clinical finding showed that patients taking Zinbryta has fewer relapse.

On the other trial, Zinbryta was compared with a placebo.  Results showed that patients taking Zinbryta has fewer relapse.

Battling with MS

According to the National Multiple Sclerosis Organization, Multiple Sclerosis is a disabling and unpredictable disease that generally targets the central nervous system. It disrupts the flow of information within the brain and even the sending of those signals to the body.

The cause of Multiple Sclerosis is still not known yet. But scientist believed that there may be environmental factors that may have triggered the activation of a genetically predisposed individual. The non-genetic factors may include problems with metabolism, exposure to virus and other environmental factors that all together cause a self-sustaining autoimmune disorder that leads to a recurrent attacks to the central nervous system.

The progression of the severity of the disease is difficult to predict considering that the symptoms varies in every individual. But most of the patients experienced episodes of reversible neurological deficits which are then followed by a progressive deterioration of the neurological condition.

It is estimated that 50% of patients with MS will need help in walking within 15 years after the disease manifest.

Most people are diagnosed at the age of 20 to 45 or 50 years old. It is more prevalent in women compared in men. Persons from the Northern European descent are also at higher risk to have MS. The disease presents in childhood or late middle age.

A Call for More Innovative Drugs

It is hard for anyone to imagine, how hard for it is for the patient and their families to survive the debilitating condition caused by MS.  The thought of losing the patient’s capacity to function normally is already a tremendous mental and emotional turmoil. Zinbryta proves to be a great drug that will help manage the disease course. Patients who failed prior treatment have another new option for their treatment plan.

Aside from the drugs, patient with MS needs to have speech, occupational and physical therapy as part of the treatment. They are also encouraged to have enough rest, take exercise and eat nutritious foods to help relieve their symptoms and have a satisfactory life.

Hopefully, these will open doors to create more innovative drugs that have lesser systemic and toxic side effects to the liver and immune system.

Works Cited

Goldenberg, M. M. (2012). Multiple Sclerosis Review. Pharmacy and Therapeutics , 175–184.

NMS. (2016). National Multiple Sclerosis Society. Retrieved May 28, 2016, from National Multiple Sclerosis Society: https://www.nationalmssociety.org/What-is-MS

 

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