FDA Approves Kesimpta® (Ofatumumab) for Relapsing Forms of MS
On August 20, 2020, Novartis announced that the United States Food and Drug Administration (FDA) approved Kesimpta® (ofatumumab) for adults with relapsing forms of multiple sclerosis (RMS), which includes clinically isolated syndrome, relapsing-remitting disease, and active secondary-progressive disease. Kesimpta is a B-cell therapy, which binds to and depletes B-cells shown to be associated with disease activity in MS. Typically this type of therapy is only available via infusion at a hospital or infusion center; however, Kesimpta is the first self-administered B-cell therapy for MS. It is given monthly via subcutaneous injection at one’s home, providing individuals with MS a new and convenient option for treating their MS.
Kesimpta is a monoclonal antibody, which is a laboratory-produced molecule that fulfills the same functions as the body’s naturally produced antibodies. Antibodies are key components of the immune system that recognize, bind to, and combat cells that can cause harm. Kesimpta is a fully human antibody, meaning that it was developed from human cells, whereas other (nonhuman) monoclonal antibodies are developed from animal cells. This newly approved medication targets CD20, a protein found on the surface of B cells, which are immune system cells believed to contribute to the development of MS.
The approval of Kesimpta is based on results from the Phase III ASCLEPIOS I and II studies, in which Kesimpta demonstrated superiority over Aubagio® (oral teriflunomide) in significantly reducing the annualized relapse rate (ARR), three-month confirmed disability progression (CDP), and the number of gadolinium-enhancing (Gd+) T1 and new or enlarging T2 lesions. These trials examined the efficacy and safety of Kesimpta relative to Aubagio in more than 1,800 people with relapsing-remitting MS (RRMS).
Results of the ASCLEPIOS I and II studies found that compared with Aubagio, Kesimpta demonstrated a significant reduction in ARR by 51% and 59% (respectively) and a relative risk reduction in three-month CDP of 34.4%. In addition, Kesimpta significantly reduced the mean number of both Gd+ T1 lesions (98% and 94% relative reduction, respectively) and new or enlarging T2 lesions (82% and 85%).
The most common side effects of Kesimpta include upper respiratory tract infection (URTI), with symptoms that include sore throat, runny nose, and headache, as well as headache not related to a URTI. Serious but less-common side effects include infections and injection-related reactions.
Novartis is offering “Alongside Kesimpta®,” a program that provides education and resources to individuals who are taking Kesimpta. For more information, please call 1-855-KESIMPTA (855-537-4678) or visit kesimpta.com.
FDA Approves Generic Version of Tecfidera®, Taken Orally for MS
On August 17, 2020, the United States Food and Drug Administration (FDA) awarded early approval of Mylan’s generic version of Biogen’s Tecfidera® (dimethyl fumarate), an oral medication approved in 2013 for relapsing forms of MS in adults. Mylan announced the launch of this generic medication on August 19, 2020, noting that this is the first generic of any MS oral treatment available to individuals in the United States. In late 2019, the FDA approved three generic versions of Gilenya® (fingolimod) oral capsules for the treatment of relapsing forms of multiple sclerosis (MS), but these are not yet commercially available.
Generic treatments have the same active ingredients and carry the same benefits and risks of the initially approved (brand-name) medication. Inactive ingredients can differ with generic medications, and generic treatments are not required to conduct the same degree of rigorous clinical trials prior to approval. As a result, generic medications are normally offered at a lower cost to the patient.
Clinical trials with Tecfidera showed a reduction in relapse rate, a delay in progression of physical disability, and a slowing in the development of brain lesions, as compared to placebo. The most commonly reported side effects are flushing and gastrointestinal events.
For more information, please call Mylan’s customer service number at (800) 796-9526.
Bafiertam™ Oral Capsules Approved by the FDA for Relapsing Forms of MS
On April 30, 2020, Banner Life Sciences LLC (Banner), a privately held specialty pharmaceutical company, announced the United States Food and Drug Administration (FDA) approval of Bafiertam™ (monomethyl fumarate) delayed-release oral capsules to treat relapsing forms of multiple sclerosis (MS). This approval includes the treatment of clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary-progressive MS (SPMS). Banner has not yet announced when the medication will be available.
Bafiertam is a “bioequivalent alternative” to Biogen’s Tecfidera® (dimethyl fumarate), which means that the active ingredient and site of action do not differ significantly between the two medications. The therapeutic effect is assumed to be equivalent. Since a lower dose of Bafiertam is equivalent to Tecfidera, this may potentially lead to a reduction in gastrointestinal (GI) side effects, such as diarrhea, nausea, vomiting, and abdominal pain. However, these side effects have not been evaluated in clinical trials in people with relapsing forms of MS.
For information about Bafiertam and its assistance program, Banner Patient Support, please visit Bafiertam.com or call 855-3BANNER (855-322-6637).
Launch of Zeposia® Announced
The commercial launch and availability of Zeposia® (ozanimod) for the treatment of adults with relapsing forms of multiple sclerosis (RMS) was officially announced on June 1, 2020. Initially approved by the United States Food and Drug Administration (FDA) on March 25, 2020, the makers of Zeposia, Bristol Myers Squibb, made the decision to delay its launch in light of the COVID-19 pandemic and the tremendous burden on the country’s healthcare system.
Given once daily as a 0.92 mg oral pill, Zeposia’s approval includes the treatment of clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary- progressive MS (SPMS). Compared to Avonex® (interferon beta-1a) in clinical trials, Zeposia reduced the annual relapse rate (ARR), demonstrated a relative reduction in brain lesions, delayed confirmed disability progression, and may prevent or delay cognitive deficits.
For information about Zeposia and the ZEPOSIA 360 Support™ Program, please visit Zeposia.com or call (833) ZEPOSIA or (833-937-6742).
For More Information
To read MSAA’s full articles on these updates, please visit mymsaa.org/news. For general information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.
Written by Susan Wells Courtney
MSAA Senior Writer
Portions written by Tom Garry
Reviewed by Dr. Barry A. Hendin
MSAA Chief Medical Officer