Regeneron and Sanofi Announce FDA Approval of Kevzara® (sarilumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis in Adult Patients
- Kevzara is now available to
"In the clinical trial program, sarilumab demonstrated statistically significant, clinically-meaningful improvements in adult patients with rheumatoid arthritis by reducing signs and symptoms and improving physical function, resulting in significantly less radiographic progression of structural damage of RA," said
RA is a chronic inflammatory autoimmune disease, which carries substantial burden. In RA, the immune system attacks the tissues of the joints, causing inflammation, pain, and eventually joint damage and disability. RA affects approximately 1.3 million Americans, with nearly 75 percent being women. It most often strikes people between 30 and 60 years old; however, it can occur in adults at any age.
"Despite the many advances made in the treatment of rheumatoid arthritis, patients continue to need new treatment options," said
"Today's milestone with Kevzara, which follows closely on the heels of our recent approval of Dupixent (dupilumab), showcases the ability of our internal discovery and science engine to deliver important new medicines by leveraging our leading technologies, such as VelocImmune," said
Kevzara may be used as monotherapy or in combination with MTX or other conventional DMARDs. The recommended dosage of Kevzara is 200 mg once every two weeks given as a subcutaneous injection, which can be self-administered. The dosage can be reduced from 200 mg to 150 mg once every two weeks, as needed, to help manage certain laboratory abnormalities (neutropenia, thrombocytopenia, and liver enzyme elevations).
The approval of Kevzara was based on data from approximately 2,900 adults with moderately to severely active RA who had an inadequate response to previous treatment regimens. In two pivotal Phase 3 clinical trials, Kevzara plus background DMARDs demonstrated statistically significant, clinically-meaningful improvements in patients with moderately to severely active RA.
In the MOBILITY study, treatment with Kevzara plus MTX reduced signs and symptoms, improved physical function, and demonstrated significantly less radiographic progression of structural damage, compared to placebo plus MTX.
- At 24 weeks, patients treated with Kevzara plus MTX achieved a greater improvement in the primary endpoint of signs and symptoms as measured by the proportion of patients achieving a 20 percent improvement in the
American College of Rheumatology Criteria(ACR20) (Kevzara 200 mg, 66 percent; Kevzara 150 mg, 58 percent; placebo, 33 percent)
- At 52 weeks, patients treated with Kevzara plus MTX demonstrated significantly less radiographic progression of structural damage as measured by the change in modified Total Sharp Score, a key endpoint of the study (placebo, 2.78; Kevzara 200 mg, 0.25; Kevzara 150 mg, 0.90)
- At 16 weeks, patients treated with Kevzara plus MTX demonstrated greater improvement from baseline in physical function as measured by the Health Assessment Questionnaire - Disability Index (HAQ-DI), a key endpoint of the study (Kevzara 200 mg, -0.58; Kevzara 150 mg, -0.54; placebo, -0.30)
In the TARGET study, treatment with Kevzara plus DMARD reduced signs and symptoms and improved physical function, compared to placebo plus DMARD.
- At 24 weeks, patients treated with Kevzara plus DMARD achieved a greater improvement in the primary endpoint of signs and symptoms as measured by the proportion of patients achieving an ACR20 response (Kevzara 200 mg, 61 percent; Kevzara 150 mg, 56 percent; placebo, 34 percent)
- At 12 weeks, patients treated with Kevzara plus DMARD demonstrated greater improvement from baseline in physical function as measured by HAQ-DI, a key endpoint of the study (Kevzara 200 mg, -0.49; Kevzara 150 mg, -0.50; placebo, -0.29)
Patients treated with Kevzara are at increased risk of developing serious infections that may lead to hospitalization or death. The most common adverse reactions (occurring in at least 3 percent of patients treated with Kevzara in combination with DMARDs vs. placebo in combination with DMARDs) observed with Kevzara in the clinical studies were neutropenia (7-10 percent vs. 0.2 percent), increased alanine aminotransferase (5 percent vs. 2 percent), injection site erythema (4-5 percent vs. 0.9 percent), upper respiratory infections (3-4 percent vs. 2 percent) and urinary tract infections (3 percent vs. 2 percent).
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 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.
- Before starting Kevzara, tell your healthcare provider if you:
- think you have an infection or have symptoms of an infection, with or without a fever, such as sweats or chills, muscle aches, cough, shortness of breath, blood in phlegm, weight loss, warm, red or painful skin or sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than normal or feel very tired; or are being treated for an infection, get a lot of infections or have repeated infections
- have diabetes, HIV, or a weakened immune system.
- have TB, or have been in close contact with someone with TB
- live or have lived, or have traveled to certain parts of the country (such as the
Ohioand Mississippi Rivervalleys and the Southwest) where there is an increased chance of getting certain fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis)
- have or have had hepatitis
- After starting Kevzara, call your healthcare provider right away if you have any symptoms of an infection.
- CHANGES IN CERTAIN LABORATORY TEST RESULTS: Your healthcare provider should do blood tests before and after starting Kevzara to check for low neutrophil (white blood cells that help the body fight off bacterial infections) counts, low platelet (blood cells that help with blood clotting and stop bleeding) counts, and an increase in certain liver function tests. Changes in test results are common with Kevzara and can be severe. You may also have changes in other laboratory tests, such as your blood cholesterol levels.
- TEARS (PERFORATION) OF THE STOMACH OR INTESTINES: Some people using Kevzara get tears in their stomach or intestine. Call your healthcare provider right away if you have fever and stomach (abdominal) pain that does not go away.
- CANCER: Kevzara may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.
- SERIOUS ALLERGIC REACTIONS: Serious allergic reactions can happen with Kevzara. Get medical attention right away if you have any of the following signs: shortness of breath or trouble breathing; feeling dizzy or faint; swelling of the lips, tongue or face; moderate to severe stomach (abdominal) pain or vomiting; or chest pain.
- Do not use Kevzara if you are allergic to Sarilumab or any of the ingredients of Kevzara.
- Before using 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 breastmilk.
- take any medicines, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you use any other medicines to treat your RA. Using Kevzara with these medicines may increase your risk of infection.
- The most common side effects include:
- injection site redness
- upper respiratory tract infection
- urinary tract infection
- nasal congestion, sore throat, runny nose
These are not all 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 negative side effects of prescription drugs to the
To learn more, talk about Kevzara with your healthcare provider or pharmacist. The
Please click here for full prescribing information including risk of SERIOUS SIDE EFFECTS and Medication Guide
Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. All Regeneron commercialized medicines were discovered and developed by our own scientists, including therapies for eye diseases, high LDL cholesterol, atopic dermatitis, rheumatoid arthritis, and a rare inflammatory condition. Regeneron also has product candidates in development in other areas of high unmet medical need, including asthma, pain, cancer and infectious diseases. Regeneron invented the leading VelociSuite® technologies, which are a suite of complementary genetics-based technologies that accelerate, improve and disrupt the traditional drug discovery and development process and established the Regeneron Genetics Center, one of the largest genetic sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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