Kevzara (sarilumab) Approved by FDA as First and Only Biologic Indicated for Patients with Polymyalgia Rheumatica
Cambridge, MA and Tarrytown, N.Y. February 28, 2023. The U.S. Food and Drug Administration (FDA) has approved Kevzara® (sarilumab) for the treatment of polymyalgia rheumatica (PMR), an inflammatory rheumatic disease, in adult patients who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. The approval is based on Phase 3 data demonstrating almost three times more patients treated with Kevzara achieved sustained remission compared to placebo.
Executive Vice President, Head, Specialty Care at Sanofi
“Until now, people living with polymyalgia rheumatica have had limited treatment options for this serious rheumatic condition which causes significant pain and discomfort. The approval of Kevzara as the first and only biologic for polymyalgia rheumatica is a new option for patients and the healthcare professionals who treat them.”
The FDA evaluated the Kevzara application for PMR under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. Kevzara was previously approved for the treatment of moderately-to-severely active rheumatoid arthritis (RA) in adult patients who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.
PMR often initially presents with pain and stiffness around the neck, shoulder, and hip area and symptoms include fatigue, low-grade fever, and weight loss. Patients often experience flares during tapering of, or relapse after discontinuation of corticosteroid treatment (CS). Patients with PMR report difficulty in carrying out everyday functions such as getting out of bed, standing up from a chair, or lifting their arms. PMR generally affects people who are 50 years and older.
George D. Yancopolous, M.D. Ph.D.
President and Chief Scientific Officer at Regeneron
“Polymyalgia rheumatica can be an incapacitating disease, causing painful disease flares in multiple parts of the bodies that leave people fatigued and unable to fully perform everyday activities. Corticosteroids have been the primary treatment to date, but many patients do not adequately respond to steroids or cannot be tapered off steroids, which puts such patients at risk of complications from long-term steroid therapy. With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”
The FDA approval for this additional indication for Kevzara is based on the results from the SAPHYR Phase 3 randomized clinical trial in patients with steroid-resistant active PMR, who flared on ≥7.5 mg/day prednisone or equivalent during taper. In the trial, patients were randomized to receive either Kevzara 200 mg every two weeks along with a 14-week taper of CS (n=60; 1 patient randomized but not treated) or placebo every two weeks along with a 52-week CS taper (n=58). At 52 weeks, the trial met its primary endpoint with 28% of Kevzara-treated patients achieving sustained remission compared to 10% for placebo (p=0.0193). Sustained remission was defined as being in disease remission by week 12, absence of disease flare, C-reactive protein normalization from weeks 12 to 52, and adherence to the CS taper protocol from weeks 12 to 52.
A sensitivity analysis removing acute phase reactants (measures of ongoing inflammation) maintained significance (proportion difference for Kevzara vs. placebo; 18%, confidence interval: 3.1 to 32.6) and confirmed the primary outcome. In addition, an analysis of a secondary endpoint showed that the median cumulative CS dose was 777 mg for Kevzara, compared to 2044 mg for placebo.
The common adverse reactions occurring in ≥5% of patients treated with Kevzara (n=59) were neutropenia (15%), leukopenia (7%), constipation (7%), rash pruritic (5%), myalgia (7%), fatigue (5%), and injection site pruritus (5%). Serious adverse reaction of neutropenia occurred in 2 patients (3%) in the Kevzara group compared to none in the placebo group (n=58). In both cases of neutropenia, the participants had a neutrophil count less than 500 per mm3 without any infections; neutropenia resolved following permanent discontinuation of study drug. The most common adverse reactions that resulted in permanent discontinuation of therapy with Kevzara were neutropenia occuring in 3 patients (5%) and infection in 3 separate patients (5%), including COVID-19 (n=1), intervertebral discitis (n=1), and pneumonia (n=1).
Sanofi is committed to helping patients in the U.S. who are prescribed Kevzara gain access to the medicine and receive the support they may need. KevzaraConnect®, a comprehensive and specialized program that provides support services to patients throughout every step of the treatment process, can help eligible patients who are uninsured, lack coverage, or need copay assistance. Additionally, KevzaraConnect offers support from registered nurses and other specialists who are available 24/7 to speak with patients and help them navigate the complex insurance process. For more information, please call 1-844-KevzaraCall: 1-844-Kevzara (1-844-538-9272) or visit www.Kevzara.com.
Kevzara is currently approved in multiple countries to treat adults with moderately to severely active rheumatoid arthritis who have not responded to or tolerated previous therapy.
Kevzara binds specifically to the IL-6 receptor and has been shown to inhibit IL-6-mediated signaling. IL-6 is an immune system protein produced in increased quantities in patients with rheumatoid arthritis and has been associated with disease activity, joint destruction and other systemic problems.
Sarilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.
U.S. Indications and Important Safety Information
KEVZARA® (sarilumab) is an injectable prescription medicine called an interleukin-6 (IL-6) receptor blocker. KEVZARA is used to treat adult patients with:
- moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease-modifying antirheumatic drug (DMARD) has been used and did not work well or could not be tolerated.
- polymyalgia rheumatica (PMR) after corticosteroids have been used and did not work well or when a slow decrease in the dose of corticosteroids (taper) cannot be tolerated.
IMPORTANT SAFETY INFORMATION
KEVZARA can cause serious side effects including:
• SERIOUS INFECTIONS: KEVZARA is a medicine that affects your immune system. KEVZARA can lower the ability of your immune system to fight infections. Some people have had serious infections while using KEVZARA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should test you for TB before starting KEVZARA. Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with KEVZARA.
• Before starting KEVZARA, tell your healthcare provider if you
- have an infection
- have liver problems
- have had stomach (abdominal) pain or a condition known as diverticulitis (inflammation in parts of the large intestine) or ulcers in your stomach or intestines
- recently received or are scheduled to receive a vaccine. People who take KEVZARA should not receive live vaccines
- plan to have surgery or a medical procedure
- are pregnant or plan to become pregnant. It is not known if KEVZARA will harm your unborn baby
- are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby if you use KEVZARA. It is not known if KEVZARA passes into your breast milk.
- take prescription or nonprescription medicines, vitamins, or herbal supplements. It is especially important to tell your healthcare provider if you use
- any other medicines to treat your RA or PMR. Using KEVZARA with these medicines may increase your risk of infection.
- medicines that affect the way certain liver enzymes work. Ask your healthcare provider if you are not sure if your medicine is one of these.
- injection site redness
- injection site itching
- upper respiratory tract infection
- urinary tract infection
- nasal congestion, sore throat, and runny nose
These are not all of the possible side effects of KEVZARA. Tell your doctor about any side effect that bothers you or does not go away. You are encouraged to report side effects of prescription drugs to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
To learn more, talk about KEVZARA with your healthcare provider or pharmacist. The FDA-approved Medication Guide and Prescribing Information can be found at www.KEVZARA.com or by calling 1-844- KEVZARA.
Please click here to see full Prescribing Information including risk of SERIOUS SIDE EFFECTS and Medication Guide.
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Posted: February 2023
- Sanofi and Regeneron Announce FDA Approval of Kevzara (sarilumab) for Rheumatoid Arthritis – May 22, 2017
- Sanofi and Regeneron Announce Kevzara (sarilumab) Biologics License Application Resubmission Accepted for Review by US FDA – April 28, 2017
- Sanofi and Regeneron Receive Complete Response Letter from FDA for Sarilumab, an Investigational Treatment for Rheumatoid Arthritis – October 28, 2016
- Sanofi and Regeneron Announce Sarilumab BLA Accepted for Review by FDA – January 8, 2016
Kevzara (sarilumab) FDA Approval History
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