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There are two encouraging news for people with progressive and recurrent forms of multiple sclerosis.
This news comes in the form of two new drugs recently approved by the Food and Drug Administration (FDA).
On March 26, FDA officials approved the Novartis drug, Mayzent (siponimod), for various forms of multiple sclerosis, including the clinically isolated syndrome, relapsing remitting multiple sclerosis and secondary active progressive multiple sclerosis.
Novartis officials announced that the pill would be available in early April. They noted that Mayzent, a once-a-day tablet, is the first treatment specifically for people with active MSPS for more than 15 years.
The annual price of treatment should be raised to $ 88,500.
On March 29, the FDA also approved EMD Serono's Mavenclad (cladribrine), also for RRMS and active SPMS, but not for the clinically isolated syndrome.
Company officials told Healthline that the annual price of treatment, estimated at $ 99,500, is expected to rise to $ 99,500.
Nearly one million people live with multiple sclerosis (MS) in the United States and about 2.3 million people worldwide.
The National Multiple Sclerosis Society's website indicates that people with RRMS have a 50% chance of switching to SPMS in the first 10 years. Another 90% have a chance of transition after 25 years.
People with relapsing forms of multiple sclerosis currently receive 15 FDA-approved DMARDs. People living with SPMS now have three choices.
The last FDA approved MS treatment was ocrelizumab in 2017. It entered the market with an annual cost of $ 65,000.
Here is an overview of the two FDA approved drugs last week.
Novartis is not new to the oral treatment of MS.
In 2010, the FDA approved Gilenya, the drug widely used by the company for the treatment of MS.
Last year, Novartis filed a lawsuit to prevent the sale of generic versions of Gilenya after the expiration of the main patent for the drug in August.
Mayzent focuses on inflammation.
"Mayzent works to sequester some white blood cells in the lymph nodes. These are considered important in the inflammatory response in MS. Kathy Costello, Nurse Practitioner at the John S Hopkins Center in Maryland and Assistant Vice President of Health Access at the National Multiple Sclerosis Society.
In the Mayzent Phase III trial in 1,651 patients, the fraction of patients with confirmed disability progression was statistically significantly lower in the Mayzent group than in the placebo group. Patients treated with Mayzent experienced a 55% relative reduction in the annualized relapse rate.
"This drug crosses the blood-brain barrier," says Dr. Timothy West, a neurologist at the University of California at San Francisco. "We do not know exactly what that does, but the results show that it slows progression in people with advanced disease."
"The immune system is activated on the periphery and plunges into the brain and wreaks havoc," he added. "We believe that in progressive MS, cells enter the brain and destroy them from within. This medicine works in the brain. Others work on the outskirts. "
Common side effects during the trials were: headache, elevated blood pressure, increased liver enzyme and reduced white blood cells that could cause an infection.
Novartis explained to Healthline that it has developed a comprehensive patient support program for Mayzent, along with MS, to help patients manage their insurance and identify resources for uninsured or uninsured people. underinsured.
Doctors are hopeful for the success of this drug.
"Mayzent has been shown to have a modest but statistically significant effect on slowing progression in people with MSPS who are still ambulatory with or without a device," says Dr. Barbara Giesser, Professor of Clinical Neurology at the David Geffen School of Medicine. Medicine from the University of California at Los Angeles and clinical director of the UCLA MS program, told Healthline.
Officials of Merck KGaA, the parent company of EMD Serono, said in a statement that Mavenclad was "the first oral treatment to provide proven efficacy of two years with up to 20 days of treatment".
Mavenclad is taken for 8 to 10 days in each of the two years of treatment. There are no other necessary treatments.
In the Mavenclad Phase III study of 1,976 participants, patients experienced a 58% relative reduction in the annual relapse rate and a 33% reduction in the rate of progression of disability, measured at baseline. using the Expanded Disability Status Scale (EDSS).
They also had fewer lesions than the placebo group.
Mavenclad works by targeting certain white blood cells (lymphocytes) at the origin of the immune attack in MS. The drug temporarily reduces the number of certain lymphocytes without continuous suppression of the immune system.
Risks include upper respiratory tract infections, headaches, herpes, alopecia and lymphopenia. Serious adverse reactions reported in the clinical program included malignancies.
The company says that because of its safety profile, this drug is generally recommended to patients who have not responded correctly or are not able to tolerate another drug indicated in the treatment of multiple sclerosis.
"The price for a person with MS will depend on the provisions of their insurance coverage and the degree to which that person will be eligible for programs designed to help cover the costs incurred," healthline officials told Healthline. EMD Serono. "The coverage will depend on individual insurance plans."
"We are determined to help patients who are prescribed Mavenclad. MS LifeLines provides personalized patient support, including help with insurance coverage issues and additional resources that can potentially help eligible uninsured or under-insured patients, "added the leaders. 39; company.
The availability of new drugs is tempered by their high costs.
"We are grateful to have another treatment available for people with MS, a treatment offering a more convenient delivery option, but this benefit is overshadowed by the very high price," said Bari Talente, Executive Vice President of the national society of MS.
"Having a new MS treatment at only six digits a year is discouraging," Talente told Healthline. "This also illustrates the price distorting effect of drugs in the United States."
Talente said that a company's price and commitment to its patients go hand in hand.
Choosing the right medicine is a basic equation of benefit / risk ratio, "added West. "It's a different equation for everyone. More options mean a better chance of finding an ideal solution for each patient. It's about adapting the right medicine to the right patient at the right time. "
West was a paid consultant for Mavenclad and was paid an advisory fee by Novartis.
Editor's note: Caroline Craven is a patient expert with MS. His award-winning blog is GirlwithMS.com, and she can be found on Twitter.
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