About MS Views and News

Within this blog you will find thousands of valuable MS related articles and resources which will enable you to learn and feel empowered with key Multiple Sclerosis information.

Please Visit our Website: www.msvn.org and our Social media platforms: Facebook, Twitter, and Instagram. Each providing knowledge for those affected by MS. *

From the comfort of your home, you can join us for our VIRTUAL MS events. To learn more of these virtual events please subscribe here.

Be empowered with MS news. CLICK HERE -to Subscribe forThe MS BEACON eNewsletter

Plus, learn from the MS Views and News Learning Channel on YouTube: www.youtube.com/msviewsandnews:


Disclaimer: 'MS Views and News' DOES NOT endorse any products or services found on this blog. It is up to you to seek advice from your healthcare provider. The intent of this blog is to provide information on various medical conditions, medications, treatments, for your personal knowledge and to keep you informed of current health-related issues. It is not a substitute for the advice of your physician. Should you or your family members have any specific medical problem, seek medical care promptly.


Wednesday, October 14, 2020

AbbVie gets orphan drug and fast track status for Elezanumab - for Myelin repair

29 September 2020 (Last Updated September 29th, 2020 12:36)

AbbVie has received orphan drug and fast track designations from the US Food and Drug Administration (FDA) for elezanumab (ABT-555) to potentially treat spinal cord injury (SCI).

AbbVie has received orphan drug and fast track designations from the US Food and Drug Administration (FDA) for elezanumab (ABT-555) to treat spinal cord injury (SCI).

Elezanumab is a monoclonal antibody of the human immunoglobulin (Ig) G1 isotype, which attaches to repulsive guidance molecule A (RGMa).

RGMa inhibits axonal outgrowth and is significant in hindering neuronal regeneration and functional recovery after damage to the central nervous system (CNS).

The FDA offers orphan drug designation to a therapeutic meant for the treatment, diagnosis or prevention of a rare disease or condition.

Meanwhile, fast track designation expedites the review of drugs for serious disorders or conditions with an unmet medical need.

AbbVie Neuroscience Development vice-president Michael Gold said: “The FDA’s orphan drug and fast track designation for spinal cord injury patients signals an important step forward in AbbVie’s ongoing commitment to investigating innovative scientific approaches with the hope of bringing new treatment options to patients.”

Studies of elezanumab to treat spinal cord injuries, as well as multiple sclerosis and acute ischemic stroke, are under progress. The drug candidate is undergoing a Phase II clinical trial for SCI.

Click HERE to Subscribe for the MS Beacon Newsletter

The randomised, double-blind, placebo-controlled Phase II trial analyses the safety and efficacy of elezanumab in acute traumatic cervical SCI. Its primary outcome is the upper extremity motor score (UEMS) at week 52.

Article source: https://www.pharmaceutical-technology.com/news/abbvie-orphan-drug-elezanumab/

Multiple-dose Study of Elezanumab (ABT-555) in Patients with Relapsing Forms of Multiple Sclerosis (S56.001)


No comments: