There are two pieces of encouraging news for people with progressive and relapsing forms of multiple sclerosis.
The news comes in the form of two new drugs recently approved by the Food and Drug Administration (FDA).
On March 26, FDA officials
Novartis officials said the pill will be available sometime in early April. They noted that Mayzent, a tablet taken once a day, is the first treatment specifically for people with active SPMS in more than 15 years.
The annual price tag is expected to be $88,500 for the treatment.
Company officials told Healthline the annual price tag is expected to be $99,500 for the two-year treatment.
The National Multiple Sclerosis Society website states that people with RRMS have a 50 percent chance of progressing to SPMS within the first 10 years. Another 90 percent have a chance of transitioning after 25 years.
People with relapsing remitting forms of MS currently have 15 FDA-approved disease modifying treatments (DMTs). People living with SPMS now have three choices.
Here’s a look at the two drugs approved by the FDA last week.
Novartis is not new to oral treatments for MS.
In 2010, the FDA
Novartis filed a lawsuit last year, seeking to block the sales of generic versions of Gilenya after the drug’s main patent expires in August.
Mayzent focuses on inflammation.
“Mayzent works to sequester certain white blood cells in lymph nodes. These are considered important in inflammatory response in MS. If they can’t get out into system then they can’t cause over inflammation in MS.” Kathy Costello, a nurse practitioner at the Johns Hopkins Multiple Sclerosis Center in Maryland and the associate vice president of healthcare access for National Multiple Sclerosis Society.
In the phase III trial of Mayzent with 1,651 patients, the fraction of patients with confirmed progression of disability was statistically significantly lower in the Mayzent group than in the placebo group. Patients treated with Mayzent had a 55 percent relative reduction in annualized relapse rate.
“This drug crosses the blood brain barrier,” explained Dr. Timothy West, a neurologist at the University of California San Francisco. “We’re not exactly sure what it does, but the results show it slows progression in those with later stage of disease.”
“The immune system is activated in the periphery and dives into brain and causes havoc,” he added. “We believe that in progressive MS cells get into the brain and destroy from the inside out. This medication works in the brain. Others work in the periphery.”
Side effects common during the trials included headaches, elevations in blood pressures, increase in liver enzyme, and a reduction in white blood cell counts that might cause infection.
Novartis shared with Healthline that it has developed a comprehensive patient support program for Mayzent, Alongside MS, to help patients navigate insurance coverage and identify resources for those who are uninsured or underinsured.
Doctors are hopeful for the drug’s success.
“Mayzent has been demonstrated to have a modest but statistically significant effect on slowing progression in persons with SPMS who are still ambulatory with or without a device,” Dr. Barbara Giesser, professor of clinical neurology at the David Geffen School of Medicine at the University of California Los Angeles and clinical director of the UCLA MS program, told Healthline.
Officials at Merck KGaA, the parent company of EMD Serono, said in a statement that Mavenclad is the “the first ever oral treatment to provide two years of proven efficacy with a maximum of 20 days of treatment.”
Mavenclad is taken for 8 to 10 days in each of the two years of treatment. There are no other treatments needed.
In the phase III study of Mavenclad with 1,976 participants, patients experienced a 58 percent relative reduction in annual relapse rate and a 33 percent reduction in rate of disability progression measured by the Expanded Disability Status Scale (EDSS).
They also experienced a lower number of lesions compared to the placebo group.
Mavenclad works by targeting certain white blood cells (lymphocytes) that lead 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 infection, headache, herpes, alopecia, and lymphopenia. Serious adverse reactions reported in the clinical program included malignancies.
The company states that due to its safety profile this drug is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of multiple sclerosis.
“Price to an individual who has MS will depend on the provisions of his/her insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out of pocket cost,” EMD Serono officials told Healthline. “Coverage will depend on individual insurance plans.”
“We are committed to helping support patients who are prescribed Mavenclad. MS LifeLines offers personalized patient support, including assistance with navigating insurance coverage questions and additional resources that may be able to help eligible patients who are uninsured or underinsured,” company officials added.
The availability of the new drugs is being tempered by their high costs.
“While we are grateful to have another treatment available for people with MS, one with a more convenient delivery option, this benefit is overshadowed by the high list price,” said Bari Talente, executive vice president of advocacy for the National MS Society.
“To have a new MS treatment priced just shy of six figures a year is disheartening,” Talente told Healthline. “This also illustrates the distorting effect of drug prices in the United States.”
Talente said price and a company’s commitment to its patients go hand in hand.
Choosing which medication is right is a basic risk benefit equation,” added West. “It is a different equation for everybody. More options mean a better chance to find a great solution for each patient. It’s about matching the right medicine to the right patient at the right time.”
West was a paid consultant for Mavenclad and has been compensated by Novartis on other projects in an advisory manner.