FDA Approves Genentech’s Enspryng, a First-in-Class IL-6R Inhibitor, as the First and Only At-Home Subcutaneous Treatment Option for Thyroid Eye Disease (TED) Freitag, 16. Oktober 2026 - 07:26

FDA Approves Genentech’s Enspryng, a First-in-Class IL-6R Inhibitor, as the First and Only At-Home Subcutaneous Treatment Option for Thyroid Eye Disease (TED)
 

• FDA approval based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement in diplopia (double vision), with a favorable safety profile, regardless of TED activity or duration
• Enspryng (satralizumab-mwge) represents an important advance for people with TED, offering the first at-home SC treatment option every four weeks during maintenance phase, allowing for greater flexibility in how treatment is administered 
• Enspryng is an anti-IL-6R mAb using novel recycling antibody technology designed to inhibit IL-6 signaling upstream of autoantibody-driven pathology
• TED is a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the U.S. that can lead to facial disfigurement and vision-threatening complications if left untreated

Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Enspryng® (satralizumab-mwge) for the treatment of adults with thyroid eye disease (TED), providing patients with the first and only at-home subcutaneous treatment option. Enspryng can be administered by a person living with TED or a caregiver following training from a healthcare provider. 

“Today’s FDA approval of Enspryng provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “As the first subcutaneous treatment for this condition, Enspryng offers a positive safety and efficacy profile and the potential for at-home administration.”

“Treating thyroid eye disease requires balancing efficacy, safety, and the practical realities of long-term treatment,” said César A. Briceño, M.D., Clinical Trial Investigator and Associate Professor of Ophthalmology at the Scheie Eye Institute, University of Pennsylvania. “As a clinical trial investigator, I have seen firsthand the potential of targeted therapies such as Enspryng. The availability of an effective subcutaneous treatment option could provide greater flexibility for both patients and physicians while reducing the logistical burden associated with infusion-based therapies. Enspryng has the potential to meaningfully expand our therapeutic options for patients with thyroid eye disease.”

The totality of data from the pivotal Phase III SatraGO program (SatraGO-1 and SatraGO-2) provided clinically meaningful improvements in patients with TED. While SatraGO-1 did not meet its pre-specified primary efficacy endpoint at week 24, SatraGO-2 achieved significant and clinically meaningful difference in proptosis response (52.9% in the Enspryng group compared to 23.4% in the placebo group) and in diplopia reduction (60.7% in the Enspryng group compared to 25.8% in the placebo group) in the active TED population. Consistent results were achieved in the overall population (including both active and chronic patients) in SatraGO-2. No new safety signals were identified in the SatraGO trials, with Enspryng’s safety profile consistent with its known profile in neuromyelitis optica spectrum disorder (NMOSD). Full results were shared at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium in October 2025.

“Thyroid eye disease not only affects a person’s eyes through bulging and vision problems, but it also takes a profound emotional toll on confidence, identity, relationships and daily life,” said Christine Gustafson, Chief Executive Officer of the TED Community Organization. “Until now, our community has had very limited choices. The approval of Enspryng represents a critical turning point through a convenient, targeted option.”

The approval in TED, following a priority review designation, marks the second indication for Enspryng, following an approval in neuromyelitis optica spectrum disorder (NMOSD) in 2020. This follows a recent acceptance by the FDA for priority review in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). Enspryng is also being studied in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signaling.

Genentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Enspryng to help minimize barriers to access and reimbursement. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or https://www.Genentech-Access.com. 

For more information, go to https://www.enspryng.com/ or call 1-844-NSPRYNG.

About SatraGO-1 and -2
SatraGO-1 (NCT05987423) and -2 (NCT06106828) are identically designed, Phase III, randomized, placebo-controlled, multicenter studies to determine the efficacy, durability and tolerability of Enspryng for the treatment of adults with active, moderate‑to‑severe TED and chronic TED. The studies enrolled a total of 258 patients from 19 countries. Participants were randomized 1:1 to receive Enspryng or placebo. The primary endpoints were the proportion of participants with active, moderate-to-severe TED who achieved an at least 2 mm reduction in proptosis in the study eye from baseline at week 24.

About thyroid eye disease (TED)
TED, also known as Graves’ ophthalmopathy, is a complex inflammatory autoimmune disease, affecting the area around the eyes and the eyes themselves, that can be sight-threatening, debilitating and disfiguring. The most common symptoms are redness, swelling of the eyes, eyelid retraction, appearance of a stare, bulging of one or both eyes (proptosis), double vision (diplopia) and pain.

TED is a progressive rare disease that affects approximately 155 people out of every 100,000. It most commonly occurs in people with hyperthyroidism, approximately 50% of whom experience at least mild TED, but it can also affect people with hypothyroidism or normal thyroid function.

Despite existing approved treatments for TED, a medical need remains for therapies that are effective, well-tolerated, and have a convenient route of administration.

About Enspryng® (satralizumab-mwge)
Enspryng, developed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that is designed to bind to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signaling, a known key pathway involved in inflammation. Enspryng incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signaling.

Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the European Union and United States, with a well established safety profile in over 16,000 patients. 

Genentech is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signaling, including autoimmune encephalitis (AIE) and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The FDA granted priority review of the Enspryng supplemental Biologics License Application (sBLA) for MOGAD in September 2026 with an approval decision expected in January 2027.

Enspryng has orphan drug designation in the United States and European Union for NMOSD and MOGAD and in the United States for anti-NMDA receptor autoimmune encephalitis (anti-NMDAR AIE) and leucine-rich glioma-inactivated 1 autoimmune encephalitis (LGI1 AIE).

Indications and Important Safety Information
What is Enspryng? 
Enspryng is a prescription medicine used to treat:

• neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive.
• thyroid eye disease (TED) no matter how severe it is or how long a person has had it.

It is not known if Enspryng is safe and effective in children.

Who should not receive Enspryng? Do not take Enspryng if you:

• are allergic to Enspryng or any of the ingredients in Enspryng.
• have an active hepatitis B infection.
• have active or untreated inactive (latent) tuberculosis.

What is the most important information I should know about Enspryng? Enspryng may cause serious side effects including:

• Infections. Enspryng can increase your risk of serious infections, some of which can be life-threatening. Talk to your healthcare provider if you are being treated for an infection, or call them right away if you think you have signs of an infection, with or without a fever, such as:
  • chills, feeling tired, muscle aches, cough that will not go away or a sore throat
  • skin redness, swelling, tenderness, pain or sores on your body
  • diarrhea, belly pain, or feeling sick
  • burning when you urinate or urinating more often than usual
• Your healthcare provider will check if you have an infection and treat it if needed before you start or continue to take Enspryng.
• Your healthcare provider should test you for hepatitis and tuberculosis (TB) before you start taking Enspryng.
• All required vaccinations should be completed before starting Enspryng. People using Enspryng should not be given ‘live’ or ‘live-attenuated’ vaccines. ‘Live’ or ‘live-attenuated’ vaccines should be given at least 4 weeks before you start Enspryng. Your healthcare provider may recommend that you get a ‘non-live’ (inactivated) vaccine, such as some of the seasonal flu vaccines. If you plan to get a ‘non-live’ (inactivated) vaccine, it should be given, whenever possible, at least 2 weeks before you start Enspryng.
• Increased liver enzymes. Your healthcare provider should order blood tests to check your liver enzymes before and while you are taking Enspryng. Your healthcare provider will tell you how often you will need to have these blood tests. Make sure you get all of your follow-up blood tests as ordered by your healthcare provider. Your healthcare provider will tell you if you need to wait to start Enspryng if your liver enzymes are increased.
• Low neutrophil count. Enspryng can cause a decrease in your neutrophil counts in your blood. Neutrophils are white blood cells that help the body fight off bacterial infections. Your healthcare provider should order blood tests to check your neutrophil count while you are taking Enspryng.
• Serious allergic reactions. Serious allergic reactions that may be life-threatening have happened with other medicines like Enspryng. Tell your healthcare provider before taking your next dose if you had hives, rash, or flushing after your injection. Seek medical attention right away if you have any symptoms of a serious allergic reaction,   such as:
  • shortness of breath or trouble breathing
  • dizziness or feeling faint
  • swelling of your lips, face, or tongue
  • moderate or severe stomach (abdominal) pain or vomiting
  • chest pain 

Before you take Enspryng, tell your healthcare provider about all of your medical conditions, including if you:

• have or think you have an infection. See "What is the most important information I should know about Enspryng?"
• have liver problems.
• have ever had hepatitis B or are a carrier of the hepatitis B virus.
• have had or have been in contact with someone with tuberculosis.
• have had a recent vaccination or are scheduled to receive any vaccination.
• are pregnant, think that you might be pregnant, or plan to become pregnant. It is not known if Enspryng will harm your unborn baby.
  • Pregnancy Registry: There is a registry for pregnant women who take Enspryng for NMOSD. The purpose of this registry is to check the health of the pregnant mother and her baby. If you are pregnant or become pregnant while taking Enspryng for NMOSD, talk to your healthcare provider about how you can join this pregnancy registry, or you may contact the registry at 1-833-277-9338 to enroll.
• are breastfeeding or plan to breastfeed. It is not known if Enspryng passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Enspryng.

Tell your healthcare provider about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the most common side effects of Enspryng? The most common side effects of Enspryng include:

• sore throat, runny nose (nasopharyngitis)
• rash
• fatigue
• extremity pain
• headache
• upper respiratory tract infection
• nausea
• inflammation of the stomach lining (gastritis)
• joint pain (arthralgia)

These are not all the possible side effects of Enspryng.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

For more information, go to https://www.enspryng.com/ or call 1-844-NSPRYNG. 

For additional safety information, please see the full Prescribing Information and Medication Guide.

About Genentech in Ophthalmology
Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases, including rare and inherited conditions.

About Genentech
Founded 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com. 

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