FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS

The U.S. Food and Drug Administration’s approval of Kesimpta (ofatumumab) this month is a pretty big deal. Kesimpta is a once-a-month injectable disease-modifying therapy. There’s nothing else like it, because Kesimpta targets B-cells in the immune system. Until now, only infusions, such as Ocrevus (ocrelizumab) and Lemtrada (alemtuzumab), have done that. After a first injection, Kesimpta can be self-administered. It seems to me that the efficacy of a B-cell attacking medication combined with the ease of self-injection should be a winner. Would you agree?

The U.S. Food and Drug Administration (FDA) has approved Novartis‘ Kesimpta (ofatumumab) as a self-administered treatment for adults with relapsing forms of multiple sclerosis (MS), meaning those with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).

According to Novartis, Kesimpta is the first approved MS therapy targeting B-cells that can be taken at home via an under-the-skin (subcutaneous) injection, using an autoinjector pen, once a month. The medication is expected to be available to patients in the U.S. in early September.

Click here to read the full story.

***

Ocrevus Cancels RRMS Patient’s Immunity to Chickenpox Virus, Case Study Finds

Many of us had chickenpox as a child, and some have been inoculated against it, creating immunity. But here’s a report of one man who, after being treated for his MS with Ocrevus (ocrelizumab), lost his immunity to the virus that causes chickenpox and shingles. While this is just a single case study, you might want to ask your neurologist about it if you’re being treated with Ocrevus or are considering that therapy.

Ocrevus (ocrelizumab) eliminated the immunity, acquired through vaccination, to the varicella-zoster virus — the virus that causes chickenpox and shingles — in a man with relapsing-remitting multiple sclerosis (RRMS), a case study reported.

Its authors recommended that MS patients being treated with Ocrevus be retested for immunity against the varicella-zoster virus.

Click here to read the full story.

***

Mylan Launching Tecfidera Generic in US

A recent court ruling that invalidated the patent protecting Tecfidera (dimethyl fumarate) has cleared the way for Mylan to begin distributing a generic version of that DMT. Without the ruling against Tecfidera’s manufacturer, Biogen, a generic wasn’t likely to become available before the patent’s expiration in 2028. Biogen says it intends to appeal the ruling, but Mylan has begun marketing its generic version anyway.

Mylan announced the launch of a first generic version of Tecfidera, a treatment for relapsing forms of multiple sclerosis (MS).

The generic, now approved by the U.S. Food and Drug Administration (FDA), is the first generic of any MS treatment available in an oral solid — capsule or tablet — form in the U.S.

Click here to read the full story.

***

Better Efforts Needed to Prevent Urinary Tract Infections in MS Patients

Urinary tract infections frequently are a problem for people with MS, due to the difficulty many of us have urinating or emptying our bladder completely. So, it seems common sense to think that treatments to improve URIs are needed. If you had any doubt, here’s a study that backs up that conclusion.

Urinary tract infections are a common cause of hospitalization among people with multiple sclerosis (MS), especially older patients with progressive disease, and more attention should be given to their bladder, catheter, and general physical care, a U.K. study reported.

These infections are often linked to an emergency hospital admission, and carry a risk of death as well as higher costs to the healthcare system, its researchers wrote.

Click here to read the rest of the story.

Have you browsed through our MS News Today Forums yet? I’m co-moderator there, and I hope you’ll give us a click to join the conversation.

***

 Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.

• Author Details

Ed Tobias

https://www.themswire.com

Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.

×

Ed Tobias

Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.

https://www.themswire.com

Latest Posts

• 
• 
• 
•