A new drug approved by the Food and Drug Administration and studied at the University of Cincinnati Gardner Neuroscience Institute wil be a game-changer for hundreds of patients treated at the Waddell Center for Multiple Sclerosis. The Waddell Center was part of the pivotal phase 3 clinical trial that led to the drug’s approval.
Approved for both types of MS and the first ever approved for the most aggressive form, it is the only drug with the most important qualities of an MS medication, says Aram Zabeti, MD, the Waddell Center’s director. “It is relatively safe and effective, and it is convenient for the patient and provider. The drug also meets the three goals of treatment. It can effectively control relapse, significantly reduce the number of future MRI lesions, and slow down the disability progression.”
The new drug, whose generic name is ocrelizumab, will be marketed by Genentech/Roche as Ocrevus. It was approved for relapsing remitting MS, the most common type, and for primary progressive MS, a rapidly debilitating condition that leads to paralysis and affects approximately 10 to 15 percent of people with MS. There previously was no treatment for primary progressive MS.
“We have been able to offer ocrelizumab to our patients since 2012 through this clinical trial and have gained a lot of experience as a result,” Zabeti says. The center is also taking part in a second clinical trial of ocrelizumab for patients who have failed other MS treatments. That trial is open for enrollment.
Drug Provides Convenience and Lower Costs
Using a unique mechanism of action that is new to MS treatment, the drug targets a subgroup of immune cells (B cells) that are believed to play an important role in the disease process by mistakenly attacking the protective myelin sheath on the axon of neurons. The drug reduced the relapse rate and disability progression in people with the relapsing form of MS by nearly half compared to an existing MS medication, Rebif, and prevented MRI lesions. Patients with primary progressive MS had a lower rate of disability progression with Ocrevus compared to patients taking a placebo.
The “convenience” factor of Ocrevus is critical, Zabeti says, because some MS medications have burdensome delivery methods, adverse side effects and tedious monitoring requirements. “Some treatments have had so much burden for the physician and the patient that the patient stops taking the medication or doesn’t follow through with the required monitoring protocols,” Zabeti says.
Studies have shown that one-half of all patients taking injectable medications for MS will stop adhering to their treatment plan within a year.
“Ocrevus is delivered by infusion only twice a year, so it will impose a relatively small inconvenience on MS patients, most of whom are young and active,” Zabeti says. “Another advantage of infusion therapy is the ability of providers to monitor patient adherence.”
Like other MS treatments, Ocrevus does have side effects. These include infusion reaction, increased risk of infection, and malignancy. While there were no cases of opportunistic infection in clinical trials, and the rate of malignancy was comparable to what is seen in the general population, Zabeti cautions that rare side effects could be discovered once the medication enters the market and is used by a large patient population. Zabeti adds that a medication that works for one patient may not work for another, and that patients should always discuss their treatment goals and plans with their doctor.
Although Ocrevus will cost $65,000 a year, Zabeti says it will be among the least expensive drugs for MS. “I was shocked and happily surprised. The MS community has been very frustrated to see drug prices increasing every year, even for a medication that was discovered 20 years ago. I think the competitive price of Ocrevus could have an impact on what other pharmaceutical companies charge.”
Genentech, a division of Roche, reported that it purposefully set the price 25 percent below the current average price of an MS medication.
The Waddell Center cares for 3,000 patients with MS at its four locations: Cincinnati, Dayton and West Chester, Ohio, and Florence, Kentucky. The Waddell clinical team is led by four neurologists (including Zabeti) who have completed fellowship training in multiple sclerosis.