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FDA Approves Kesimpta® (ofatumumab), Similar to Ocrevus®, for Relapsing MS

August 21, 2020


SUMMARY
  • The U.S. Food and Drug Administration has approved Kesimpta® (ofatumumab, Novartis) as an injectable disease-modifying therapy for adults with relapsing forms of MS, including clinically isolated syndrome (an initial neurological episode), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity.
  • The approval was based on two identical phase 3 studies (ACLEPIOS I and II) in which participants were randomly assigned to receive Kesimpta (self-injected once a month), or daily oral Aubagio® (teriflunomide, Sanofi Genzyme) for up to 30 months. The primary outcome measured was the annual rate of relapses. Secondary endpoints included time to progression of disability, rate of brain volume loss and other measures.
  • Kesimpta reduced annual relapses significantly more than Aubagio, reduced disability worsening at three months, and reduced disease activity on MRI scans.
  • Kesimpta is a therapy that depletes specific immune B cells. It is a monoclonal antibody that binds to a docking site (CD20) on some immune B cells and depletes them. B cells are among immune cells that have been implicated in causing nervous system damage in MS. Another B-cell therapy currently approved to treat MS is Ocrevus® (Genentech).
  • The most common potential side effects include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions.
  • Prescribing information cautions that Kesimpta should not be administered in individuals with active infection, and live or live-attenuated vaccines are not recommended during treatment and after discontinuing treatment until B cells return. Because Kesimpta reduces B cells that make immunoglobulins to help fight infections, levels should be monitored before, during, and after treatment. Because of the risk for fetal harm, women are cautioned to use birth control during and for 6 months after stopping Kesimpta. 
“We are pleased that there is a new treatment option for people with relapsing MS,” said Kathy Costello, MS, ANP-BC, MSCN, Associate Vice President of Healthcare Access at the National MS Society.
 
Download prescribing information (.pdf).
Download the Medication Guide for patients (.pdf)

FURTHER DETAILS
About Kesimpta: Multiple sclerosis involves immune system attacks that cause inflammation and damage in the brain and spinal cord tissues. In the same class as ocrelizumab (Ocrevus®, Genentech), Kesimpta is a therapy that depletes specific immune B cells. B cells are among immune cells that have been implicated in causing nervous system damage in MS. Kesimpta is a monoclonal antibody that binds to a docking site (CD20) on immune B cells (lymphocytes) and depletes them.
 
Clinical Trials: Two identical Phase 3 trials tested Kesimpta versus oral Aubagio in more than 1800 people with relapsing-remitting MS or active secondary progressive MS for up to 30 months. Participants had to have experienced at least one relapse in the previous year, two relapses in the previous two years, or had an MRI-detected active lesion (gadolinium-enhancing) in the previous year. Participants were randomly assigned to receive Kesimpta, self-injected once a month, or daily oral Aubagio. As a control, the groups also received placebo versions of Kesimpta or Aubagio. The primary outcome measured was the annual rate of relapses. Secondary endpoints included time to progression of disability, effect on MRI-detected brain lesions, brain volume loss and other measures.
 
Potential Benefits: Compared to those on Aubagio, Kesimpta significantly reduced annualized relapse rates relative to Aubagio (a relative reduction of 51 to 59% in the two studies), active MRI-detected lesions (a relative reduction of 94 to 98%), new or enlarging lesions (a relative reduction of 82 to 85%), and disability progression sustained over 3 months (a relative reduction of 34.4%). According to the recently published study results, brain tissue loss was not reduced significantly more in the Kesimpta group.
 
Potential Risks: The most common adverse events include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions. Prescribing information contains a warning that Kesimpta should not be administered in individuals with an active infection until that infection is resolved. Live or live-attenuated vaccines are not recommended during treatment and after discontinuing treatment until B cells return. Levels of immunoglobulins, which help fight infections, should be monitored before, during, and after treatment. Because of the risk for fetal harm, women are cautioned to use contraception during and for 6 months after stopping Kesimpta.
 
PML (progressive multifocal leukoencephalopathy) may occur when taking Kesimpta. PML is a rare, serious brain infection that can result in death or severe disability. Individuals are cautioned to tell their healthcare providers if experiencing any new or worsening neurological symptoms such as weakness on one side of the body, loss of coordination in arms and legs, vision problems, changes in thinking and memory, or confusion and personality changes.
 
Pre-dosing Tests and Dosing: Individuals prescribed Kesimpta are required to have blood tests to screen for the presence of Hepatitis B virus (HBV), and for serum levels of immunoglobulins. When starting Kesimpta, individuals will take injections each week for 3 weeks, and thereafter will take Kesimpta monthly. 

Novartis has announced that Kesimpta should be available for prescription by September 2020.
 
Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting an MS therapy should be done by people with MS in collaboration with their MS healthcare provider, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.
 
For more information about the availability of Kesimpta and support programs from the company, individuals may call:
1-855-KESIMPTA (1-855-537-4678), 8:30 am–8:00 pm ET, Mon–Fri.
Or visit www.kesimpta.com.
 
Download prescribing information (.pdf).
Download the Medication Guide for patients (.pdf)
Read more about disease-modifying therapies and other treatments for MS and MS symptoms
 
Aubagio is a registered trademark of Sanofi Genzyme
Kesimpta is a registered trademark of Novartis
Ocrevus is a registered trademark of Genentech, a member of the Roche Group

FAQ About FDA’s Approval of Ofatumumab – Brand name Kesimpta® – for Relapsing MS

Q. What types of MS is Kesimpta approved to treat?
A. The FDA has approved Kesimpta for the treatment of relapsing forms of MS, including clinically isolated syndrome (an initial neurological episode), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity.
 
Q. How is Kesimpta taken?
A. Kesimpta is self-administered as a monthly under-the-skin injection. The first three doses are self-injected weekly, then switching to once monthly starting with week 4.
 
Q. What are the potential side effects of Kesimpta?
A. The most common side effects include upper respiratory tract infection, headache, injection-related reactions, and local injection site reactions. The Prescribing Information (.pdf) provides full information on potential side effects.
 
Q. Why should a person with MS consider taking a disease-modifying therapy?
A. Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future disability. Studies comparing people in clinical trials who started therapy earlier than those on inactive placebo suggest that early treatment offered important benefits against the accumulation of disability, which were generally not experienced to the same degree by those who started treatment later.
 
Q. Should I switch from my current therapy to Kesimpta?
A. The decision about whether to take Kesimpta should be made in collaboration with your MS healthcare provider, taking into account a variety of factors including the effectiveness of any therapy you are currently using, the potential risks and benefits, as well as costs and lifestyle factors. Important questions to be considered and discussed with your doctor in terms of Kesimpta include:
  • How am I doing on my current therapy?
  • What is my tolerance for the risk of known side effects?
  • What is my tolerance for the risk of adverse consequences that might emerge with longer-term use?
  • Does the administration schedule fit into my lifestyle?
  • Will I remember to take it as prescribed?
  • How will my medication choice affect my ability or plans to become pregnant?
  • What are the comparative costs of my current therapy versus Kesimpta?

Q. How long would a person take Kesimpta?
 A. There is no specified time limit for taking Kesimpta.
 
Q. Are there any risk factors or medical conditions that would make it inappropriate for an individual to take Kesimpta?
A. Kesimpta should not be administered in individuals with an active infection until that infection is resolved. In people with a history of hepatitis B virus infection, the virus may become reactivated, which can cause serious liver problems. Because of the risk for fetal harm, women are cautioned to use birth control during and for 6 months after stopping Kesimpta.  
 
Q. May I start Kesimpta during the COVID-19 pandemic?
A. Before starting on any new disease-modifying therapy, people with MS should discuss with their healthcare professional which therapy is the best choice for their individual disease course and disease activity in light of COVID-19 risk in their region. Therapies that target CD20 – including Kesimpta (ofatumumab), Ocrevus (ocrelizumab), and Rituxan (rituximab)– may be linked to an increased chance of being admitted to hospital or requiring intensive care treatment due to COVID-19. This preliminary finding requires further investigation.
 
Q. Will a person taking Kesimpta have to get any special medical tests or monitoring?
A. Individuals prescribed Kesimpta are required to have blood tests to be screened for the presence of Hepatitis B virus (HBV), and to be screened for serum levels of immunoglobulins before, during and after discontinuing treatment until B cells return.
 
Q. What will Kesimpta cost?
A. The wholesale acquisition price of Kesimpta has been announced as $83,000 per year. The actual cost to an individual who has MS will depend on the provisions of their insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs.
 
Q. Will my health insurance cover Kesimpta?
A. Coverage will depend on individual insurance plans.
 
Q. Is there a generic form of Kesimpta?
A. No.
 
Q. Where can I get information about the patient support that Novartis plans to provide?
A. For more information about the availability of Kesimpta and support programs from the company, individuals may call:
1-855-KESIMPTA (1-855-537-4678), 8:30 am–8:00 pm ET, Mon–Fri.
Or visit www.kesimpta.com.
 
Q. Is Kesimpta being tested in primary progressive MS or non-active secondary-progressive MS?
A. Not at this time.

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system. Symptoms range from numbness and tingling to blindness and paralysis, and there is currently no cure for MS. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. An estimated 1 million people live with MS in the United States. Most people with MS are diagnosed between the ages of 20 and 50, and it affects women three times more than men.

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