How Fingolimod Hydrochloride Limits MS Relapses in Children and Adults


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How Fingolimod Hydrochloride Limits MS Relapses in Children and Adults

Fingolimod Hydrochloride blog
Drug Research & Development API, Immunosuppressant

Fingolimod Hydrochloride CAS: 162359-56-0

Fingolimod HydrochlorideFingolimod Hydrochloride is typically given to those who suffer from multiple sclerosis (MS) relapses. It doesn’t eliminate episodes in the body entirely, but it can reduce them by 50% or more over the course of several years. When the body is having an autoimmune reaction, the lymphocytes play a big role in the body’s reaction. Fingolimod Hydrochloride can cordon off the lymphocytes from the brain, which can vastly improve the quality of life for those with the relapsing version of the disease. It can also help those with chronic inflammatory demyelinating polyneuropathy.

History and Mechanisms

First manufactured by a Japanese pharmaceutical company in the early 1990s, this API first went through a number of tests and experiments before being approved by the FDA. In 2010, it became the first oral API to be sanctioned to help combat relapse MS and delay disability progression. In 2011, it was approved for both the Canadian and European Union market. Fingolimod Hydrochloride comes from the fungus Isaria sinclairii. It works with the S1P receptors to keep the lymphocytes in the nodes where they belong. If the lymphocytes are unable to make their way into the central nervous system, they cannot cause a relapse of MS.

Pediatric Use

In a Phase 3 trial, it was found that Fingolimod Hydrochloride could help pediatric children with MS. At the 2018 American Academy of Neology Annual Meeting in California, researchers presented their results after testing 215 pediatric patients between the ages of 10 and 18 throughout 25 countries. After studying the safety and efficacy of the API, they found the flare-ups for MS were vastly controlled as compared to a competing API used during the study, and that Fingolimod was effective at delaying brain deterioration. In fact, more than 95% of patients who were treated with the API showed no signs of disability progression after three months work of treatment. These findings mean an expedited approval to fast-track this API to the market.

Additional Treatment Options

Fingolimod Hydrochloride not only suppresses the immune system’s unnecessary reactions, but it’s also a general force of good for the central nervous system. It’s been reported to help the glial and precursor cells heal themselves in the event of an injury, and suppress the ongoing progression of the debilitating chronic inflammatory demyelinating polyneuropathy. This disease limits the sensory function a person has in their limbs, and typically occurs in young people. Its ability to inhibit CPLA2 and ceramide synthase will likely open up the doors for additional treatment paths for more diseases and conditions further down the line.

Side Effects

Fingolimod Hydrochloride typically causes cold-like symptoms, including headaches and general fatigue. In severe cases, the API may make people more prone to infections, though this link is not entirely established. Skin cancer, hemorrhaging, and zoster have also been reported, though again, it’s not clear how much Fingolimod Hydrochloride contributed to these extreme reactions. What is known is that the treatment of Fingolimod Hydrochloride can result in macular edema, a condition that can adversely interfere with the patient’s vision. Doctors are highly encouraged to monitor their patients via ECG during the first dose of treatment to limit the chances such events will occur.

LGM Pharma

LGM Pharma is an innovation-driven API company, involved in the distribution of quality cGMP pharma ingredients to leading pharmaceutical companies. We specialize in streamlining the API supply chain management throughout all development and commercial stages while providing complete technical capabilities, expert regulatory support as well as other value-added services.

Sources:

#AAN2018 – Review of Phase 3 Trial Data Supports Gilenya as Treatment for Pediatric MS


https://en.wikipedia.org/wiki/Fingolimod
https://pubchem.ncbi.nlm.nih.gov/compound/Fingolimod_hydrochloride#section=InChI

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