FDA Approves Saphnelo: First New Systemic Lupus Erythematosus (SLE) Medication in 10 Years

Last week, AstraZeneca announced that the FDA approved Saphnelo (anifrolumab-fnia), a first-in-class medication for adults with moderate to severe systemic lupus erythematosus (SLE or “lupus”) who are receiving standard therapy. There are a few different types of lupus, but SLE — inflammation that affects multiple organs or organ systems — is the most common.

Saphnelo is the first new SLE medication to be approved in over 10 years. The approval follows the 2011 approval of Benlysta (belimumab), the first FDA-approved biologic lupus medication. AstraZeneca, Saphnelo’s manufacturer, is also studying the medication for other lupus indications (uses).

Read on to learn more about Saphnelo’s approval — how it works, what to expect from treatment, and when it’ll be available.

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Important Safety Information

Do not use BENLYSTA if you are allergic to belimumab or any ingredients in BENLYSTA.
The most important information about BENLYSTA
Immunosuppressive agents, including BENLYSTA, can cause serious side effects. Some of these may cause death.
• Infections:
fever, chills, pain or burning with urination, urinating often, coughing up mucus, or warm, red, or painful skin or sores on your body. Infections could be serious, leading to hospitalization or death.
• Allergic (hypersensitivity) reactions:
itching, swelling of the face, lips, mouth, tongue, or throat, trouble breathing, anxiousness, low blood pressure, dizziness or fainting, headache, nausea, or skin rash. Serious allergic reactions can happen the day of, or in days after, receiving BENLYSTA and may cause death.
• Mental health problems and suicide:
thoughts of suicide or dying, attempt to commit suicide, trouble sleeping (insomnia), new or worse anxiety or depression, acting on dangerous impulses, other unusual changes in your behavior or mood, or thoughts of hurting yourself or others.

Before receiving BENLYSTA, discuss with your healthcare provider if you:
• think you have an infection or have infections that keep coming back. Do not use BENLYSTA if you have an infection unless your healthcare provider tells you to.
• have or have had mental health problems such as depression or thoughts of suicide.
• have recently received or may need a vaccination. If you are receiving BENLYSTA, you should not receive live vaccines.
• are taking any medicines, including prescription, over-the-counter, vitamins, and herbal supplements.
• are allergic to other medicines.
• are receiving other biologic medicines.
• have or have had any type of cancer.
• have any other medical conditions.
• are pregnant or plan to become pregnant. It is unknown if BENLYSTA will harm your unborn baby. Talk to your healthcare provider about whether to prevent pregnancy while on BENLYSTA. If you choose to prevent pregnancy, you should use an effective method of birth control for at least 4 months after the final dose of BENLYSTA.
• become pregnant while receiving BENLYSTA, talk to your healthcare provider about enrolling in the BENLYSTA Pregnancy Registry. You can enroll in this registry by calling 1-877-311-8972 or go to https://mothertobaby.org/ongoing-study/benlysta-belimumab/
• are breastfeeding or plan to breastfeed. It is unknown if BENLYSTA passes into your breast milk.

Possible side effects of BENLYSTA
• Progressive multifocal leukoencephalopathy (PML). PML is a serious and life-threatening brain infection. PML can result in death or severe disability. Tell your healthcare provider right away if you notice any new or worsening medical problems: memory loss, trouble thinking, dizziness or loss of balance, difficulty talking or walking, or loss of vision.
• Cancer. Medicines that affect the immune system, including BENLYSTA, may increase your risk of certain cancers.

The most common side effects of BENLYSTA are nausea, diarrhea, fever, stuffy or runny nose and sore throat, persistent cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection (when given subcutaneously). These are not all the possible side effects of BENLYSTA. Call your doctor for medical advice about side effects.

Please see Prescribing Information and Medication Guide for BENLYSTA.

What is BENLYSTA?
BENLYSTA is a prescription medicine used to treat people 5 years of age and older with active systemic lupus erythematosus (SLE or lupus) or active lupus nephritis (LN) (lupus-related kidney inflammation) who are receiving other lupus medicines. It is not known if BENLYSTA is safe/effective in people with severe active central nervous system lupus.

It is not known if BENLYSTA, given under the skin, is safe/effective in:
• children with SLE under 5 years of age or weighing less than 33 lbs
• children with LN under 18 years of age
It is not known if BENLYSTA, given in a vein (intravenously), is safe and effective in children less than 5 years of age.

BENLYSTA IV is available as 120 mg in a 5-mL single-dose vial and 400 mg in a 20-mL single-dose vial. BENLYSTA SC is available as a 200 mg/mL single-dose autoinjector and prefilled syringe.

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What is Saphnelo?

Saphnelo (anifrolumab-fnia) is an injectable monoclonal antibody — a lab-made protein that targets specific substances in your body. It’s also considered a biologic, which is a therapy made from proteins, viruses, and living organisms.

Saphnelo is approved to treat moderate to severe lupus in adults who are receiving standard therapy, which includes medications like oral corticosteroids (e.g., prednisone), antimalarials (e.g., hydroxychloroquine), and immunosuppressants (e.g., methotrexate, azathioprine). 

This means that Saphnelo is used in addition to other lupus medications — not by itself. Your healthcare provider might decide that Saphnelo is a good add-on medication if your SLE isn’t well-controlled with standard therapies.

How does Saphnelo work for lupus?

Saphnelo works by targeting a specific receptor (chemical binding site) — called the type I interferon (IFN) receptor. This blocks type I IFN activity, which is thought to play a role in more active and severe disease. Saphnelo is the first lupus medication that works this way.

However, Saphnelo had mixed results during phase 3 clinical trials — the last step before applying for FDA approval. When assessing disease activity and improvement to see if a treatment is effective, studies will use different measurement tools. And it’s possible that treatments may show a benefit with one, but not all, of those used in a study. 

For example, the first Saphnelo study (TULIP-1) didn’t meet its primary endpoint (objective) when measuring response rates using the SLE Responder Index 4 (SRI4) — a tool that helps determine SLE improvement and treatment effectiveness. 

But it did meet a few secondary endpoints, including the BILAG-Based Composite Lupus Assessment (BICLA) scale response. Both SRI4 and BICLA help to measure treatment response but have different criteria for what’s considered to be an improvement.

The second study (TULIP-2) met its primary endpoint using the BICLA scale (instead of SRI4). This primary endpoint showed that Saphnelo was more effective than placebo — a substance with no medication — at helping control SLE severity over the course of 1 year. A few secondary endpoints also resulted in a significant benefit — like lowering required oral corticosteroid doses and helping improve skin disease severity.

Because of these findings, it was suggested that Saphnelo could provide a benefit for people with SLE.

How is Saphnelo dosed?

Saphnelo is an intravenous (IV) infusion that’s administered by a healthcare professional. The infusion is given over 30 minutes, and you’ll need to get it every 4 weeks. 

Saphnelo doesn’t have a specific minimum or maximum duration of use. If your healthcare provider decides that you may benefit from this medication, they can help determine how long you’ll likely use it for. 

What are the potential side effects of Saphnelo?

Since lupus is an autoimmune disorder — a condition where your immune system attacks your own body — medications used to treat it typically work by suppressing your immune system. This holds true for Saphnelo.

However, medications that suppress your immune system can also raise your risk of getting an infection, especially respiratory infections and herpes zoster (shingles). Because of this, it’s important to let your provider know about any active, chronic, or recurrent infections before treatment — and if any infection symptoms (e.g., fever, cough) show up after your infusion.

The most common side effects of Saphnelo include:

• Upper respiratory tract infections (URTIs)

• Bronchitis

• Infusion-related reactions (e.g., headache, nausea, fatigue)

• Herpes zoster (shingles)

• Cough

It’s also possible to have a hypersensitivity reaction — which can include life-threatening allergic reactions — to Saphnelo. Your provider will monitor you for reactions during your infusion. Call 911 or seek emergency medical attention if you start experiencing shortness of breath, swelling of your face, throat, or tongue, or feeling like you’re going to pass out after your infusion.

Medications that suppress your immune system may raise your risk of developing cancer. Because Saphnelo is an immune system suppressant, it carries a cancer risk warning. Let your provider know about any personal or family history of cancer before starting this medication.

Can Saphenlo interact with other medications?

Medication interaction studies haven’t been conducted at this point, so we don’t know which medications may interact with Saphnelo. 

However, it isn’t recommended you use Saphnelo with other biologic medications. This means that you shouldn’t use it in combination with the other FDA-approved biologic lupus medication, Benlysta.

Since you may be taking a biologic for other conditions outside of lupus, make sure your provider knows your current medications before starting Saphnelo. It’s not recommended to use Saphnelo at the same time as other biologics. 

Additionally, since Saphnelo works by suppressing your immune system, you shouldn’t receive live or live-attenuated (weakened) vaccines — like chickenpox and measles, mumps, and rubella (MMR) — while on Saphnelo.

How does Saphnelo compare to other lupus medications?

While Saphnelo and Benlysta are both biologic monoclonal antibody medications for people with lupus on standard therapy, they work differently and have different specific uses. Let’s review a few key differences.

Administration

First, both medications are available as an IV infusion that’s administered every 4 weeks. However, Benlysta is also available as an injection given just under the skin (subcutaneously) once weekly. 

Saphnelo is currently being studied for subcutaneous administration, so we may see this option approved in the future.

Indications

Both medications are to be used in addition to standard therapy — but their approved indications and age groups are different.

Benlysta is approved for active, autoantibody-positive lupus in adults and children at least 5 years old, as well as lupus nephritis (kidney disease caused by lupus) in adults. Autoantibodies — immune memory cells that target your own healthy cells — are commonly tested if lupus or another autoimmune condition is suspected. 

Saphnelo is approved for moderate to severe lupus in adults. Although it’s being studied, it’s not yet approved for lupus nephritis. Saphnelo is also being studied for cutaneous lupus erythematosus — a form of skin disease — and myositis (muscle inflammation). 

How they work

Both medications are monoclonal antibodies, but they work on different parts of the immune system. Saphnelo works by targeting type I IFN receptors. Benlysta works by binding to a protein called B-lymphocyte stimulator (BLyS), which helps lower certain immune cells and autoantibodies.

When will Saphnelo be available?

AstraZeneca, Saphnelo’s manufacturer, hasn’t stated when it will be available. Since it will initially be available as an infusion, it needs to be administered by a healthcare professional. This means that you won’t be able to find it at the pharmacy just yet, but there’s a potential that one day it may be available as an at-home injection. We’ll also know more about potential costs and coverage once it’s available.

However, if you’re interested in giving Saphnelo a try, talk to your healthcare provider to see if it’s right for you. 

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Written by:

Alyssa Billingsley, PharmD

Alyssa Billingsley, PharmD, is the director of pharmacy content for GoodRx. She has over a decade of experience as a pharmacist and has worked in clinical, academic, and administrative roles.

Reviewed by:

Joshua Murdock, PharmD, BCBBS

Joshua Murdock, PharmD, BCBBS, is a licensed pharmacist in Arizona, Colorado, and Rhode Island. He has worked in the pharmacy industry for more than 10 years and currently serves as a pharmacy editor for GoodRx.

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