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Discover what ENSPRYNG has to offer

ENSPRYNG was proven to reduce the risk of relapse in AQP4-IgG(+) adults with neuromyelitis optica spectrum disorder (NMOSD)

Study 1: Participants treated with ENSPRYNG alone vs placebo

Study 1 looked at patients taking ENSPRYNG on its own and excluded patients who were recently taking other treatments before starting the trial.

A wide range of patients in terms of age, gender, AQP4-IgG status, and severity of disease were represented in both clinical trials:

  • Men and women, with a larger proportion of women
  • Patients who were AQP4-IgG(+) or AQP4-IgG(-)
  • Patients with at least 1 confirmed relapse over the past year

The study included 95 patients who were AQP4-IgG(+) or AQP4-IgG(–) to randomly receive either ENSPRYNG or placebo. Of the 64 who were AQP4-IgG(+), 41 patients received ENSPRYNG and 23 patients received placebo.

ENSPRYNG is only approved for AQP4-IgG(+) adults

ENSPRYNG significantly reduced the risk of relapse and more people were relapse-free on ENSPRYNG vs placebo at about 2 years (96 weeks)

ENSPRYNG reduced the risk of relapse by 74% in AQP4-IgG positive participants. 8 out of 10 participants were relapse free at 96 weeks vs 4 out of 10 participants taking placebo.

Study 2: Participants treated with ENSPRYNG plus IST vs placebo plus IST

Study 2 only included patients who were taking certain ISTs (azathioprine, mycophenolate mofetil, or oral corticosteroids) before starting the trial.

A wide range of patients in terms of age, gender, AQP4-IgG status, and severity of disease were represented in both clinical trials:

  • Men and women, with a larger proportion of women
  • Patients who were AQP4-IgG(+) or AQP4-IgG(-)
  • Patients with at least 1 confirmed relapse over the past year

The study included 76 patients who were AQP4-IgG(+) or AQP4-IgG(–) to randomly receive either ENSPRYNG plus IST or placebo plus IST. Of the 52 who were AQP4-IgG(+), 26 patients received ENSPRYNG and 26 patients received placebo.

ENSPRYNG is only approved for AQP4-IgG(+) adults

ENSPRYNG significantly reduced the risk of relapse and more people were relapse-free on ENSPRYNG plus IST vs placebo plus IST at about 2 years (96 weeks)

ENSPRYNG reduced the risk of relapse by 78% in AQP4-IgG positive participants. 9 out of 10 participants were relapse free at 96 weeks vs 6 out of 10 participants taking placebo.

Select Important Safety Information for ENSPRYNG

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.

For more details, see the continued Important Safety Information below.

Dr. Adil Javed explains the ENSPRYNG studies

Get a clear explanation of how ENSPRYNG was studied, the results from each study, and what they could mean for you.

ENSPRYNG Clinical Studies

Voice-Over:

The subject of this video is “Clinical Trial Results for ENSPRYNG.” ENSPRYNG is a prescription medicine used to treat neuromyelitis optica spectrum disorder, also known as NMOSD in adults who are aquaporin-4, also known as AQP4, antibody positive.

It is not known if ENSPRYNG is safe and effective in children. ENSPRYNG may cause serious side effects, including infections, increased liver enzymes, and low neutrophil counts.

All required vaccinations should be completed before starting ENSPRYNG. Do not take ENSPRYNG if you are allergic to satralizumab-mwge or any of the ingredients in ENSPRYNG, have an active hepatitis B infection, or have active or untreated inactive (latent) TB.

Please see Important Safety Information at the end of this video. If you have any questions, please talk to your healthcare provider or refer to the ENSPRYNG Prescribing Information and Medication Guide.

This video features an accredited neurologist and a real person who is treating her NMOSD with ENSPRYNG.

 

KILA:

Hello, my name is Kila. I was misdiagnosed with MS back in 2014. After a series of tests and hospital visits, they determined I actually had AQP4 positive NMOSD. It was very frustrating. So, if you were diagnosed with NMOSD or misdiagnosed like I was, I know what you are going through as you look to learn more about this rare disease and consider your treatment options. This is one video in a series. I wish I would’ve had these videos to turn to when I was first diagnosed with NMOSD. Today’s topic covers the clinical trial results for ENSPRYNG.

In plain English, that means we will review the studies that were done with real NMOSD patients treated with ENSPRYNG. Today, we are fortunate to have a doctor with us who will share these results with you and explain what they mean.

I totally see NMOSD as a disease that is manageable. I take ENSPRYNG, as prescribed by my doctor, so that I can reduce my risk of relapse. Now, let’s hear what Dr. Javed has to say about these important clinical trials.

 

DR. ADIL JAVED:

Thanks, Kila. Hello, my name is Dr. Javed. I’m a neurologist. As Kila pointed out, I’m here to talk about the two clinical studies that were done for ENSPRYNG. ENSPRYNG is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are aquaporin-4 antibody positive. Before a drug goes to the market, it gets tested on real patients in a clinical trial. As we review these two studies on the next few slides, I will explain the data the same way I would when I explain to one of my patients. First, let’s take a look at the goals of these clinical trials. A clinical trial tests how well a medical treatment works in people and can determine whether a new treatment is beneficial and safe.

As you can see on the slide, there were two clinical trials done for ENSPRYNG. The two trials were conducted to determine whether taking ENSPRYNG alone or taking ENSPRYNG with immunosuppressive therapy, also known as IST, could lower the risk of relapse in adults with NMOSD versus placebo.

The goal of both trials was to measure how many patients were relapse-free at specific points in time with treatment. In our next slide, we will look at what kind of patients were chosen to participate in the clinical trials. This is very important. The idea is to test as diverse a patient population as possible. Men, women, various ethnicities and ages.

Differences between people such as gender, age, ethnicity and where they live can produce different reaction to the same treatment. Therefore, it is important to have a diverse sample size that is representative and inclusive but not restrictive. The two trials include patients from various countries all around the world. The trials were conducted on both men and women, but women represented a larger percentage of patients.

The study included patients who are either aquaporin-4-IgG positive or negative. In addition, patients had to have at least one confirmed relapse within the last year. Study 1 did not include patients who were recently taking other treatments before starting the trial. Study 2, on the other hand, only included patients who were taking certain ISTs, such as azathioprine, mycophenolate mofetil, or oral corticosteroids before starting the trial.

I encourage my patients to ask a lot of questions. I urge you to do the same. When your doctor discusses a treatment with you, don’t be afraid to ask who it was tested on, how was it studied, how many clinical studies were done. ENSPRYNG is the only NMOSD therapy proven in two clinical studies. Let’s review the patients that were included in Study Number 1.

The study looked at 95 different patients. Each patient was randomly given either ENSPRYNG or a placebo. Sixty-four of the patients were aquaporin-4-IgG positive. Forty-one received ENSPRYNG. Twenty-three were given a placebo.

Thirty-one aquaporin IgG negative. Now, let’s go over the patients from Study Number 2. This study included 76 patients in total. The patients were randomly given either ENSPRYNG plus IST or a placebo plus IST.

Fifty-two of the patients were aquaporin-4-IgG positive. Twenty-six received ENSPRYNG. Twenty-six were given a placebo. Twenty-four were aquaporin-4-IgG negative. ENSPRYNG is only approved for aquaporin-4-IgG positive adults. I would say the number one concern of my patients with NMOSD is reducing the risk of relapse.

Let’s see how ENSPRYNG performed in reducing the risk of relapse in Study 1. Looking at the results from Study 1, we can see that ENSPRYNG significantly reduced the risk of relapse by 74% in patients who are aquaporin-4-IgG positive. After 96 weeks of Study 1, more ENSPRYNG patients (77%) were relapse-free than with placebo, which had just 41%.

Eight out of 10 aquaporin-4-IgG positive patients on ENSPRYNG were relapse-free while 4 out of 10 were relapse-free with placebo. Before we review the data from Study 2, I’d like to point out a difference between the two studies. Study 1 measured ENSPRYNG as a treatment alone versus placebo. Study 2 was done on patients who took ENSPRYNG plus IST versus patients who took placebo plus IST.

If you are a patient on immunosuppressive therapies, the data from Study 2 would be important for your doctor to know. If you are a patient who is not on immunosuppressive therapy, then your doctor will be more interested in the data from Study 1. Now, let’s look at the risk of relapse data from Study 2.

As you can see from the slide, ENSPRYNG significantly reduced the risk of relapse by 78% in patients who are aquaporin-4-IgG positive. The numbers show that more patients taking ENSPRYNG plus IST were relapse-free than patients taking placebo plus IST. 91% for ENSPRYNG versus 57% for the placebo. The time frame of Study 2 was the same as Study 1. After 96 weeks of testing, 9 out of 10 patients on ENSPRYNG plus IST were relapse-free versus 6 out of 10 on placebo plus IST.

I hope all the data didn’t overwhelm you. In my opinion, there are a few key takeaways from this. The numbers show that ENSPRYNG does help reduce the risk of relapse whether a patient is taking ISTs or not. And the best way to know if ENSPRYNG can be a part of your treatment plan is to talk to your doctor and discuss all the benefits and risks of ENSPRYNG.

I urge you to become your own advocate and take advantage of all the resources out there that go into even more detail about living with NMOSD. Now that we have reviewed the data from the clinical studies, let’s hear how that translates into everyday life of a real NMOSD patient. Let’s hear from Kila. Thank you for your time.

 

KILA:

Thanks, Dr. Javed. My doctors and I are happy with my results on ENSPRYNG. Of course, everyone’s experience with ENSPRYNG is different. I know a relapse could always be a possibility, so I keep in good contact with my neurologist, and we talk about all the different issues that I may be having.

Living with NMOSD, I feel it is important for me to do something for myself every day. I love to take my dogs on walks. Some days I just go maybe a block, and then other days I feel better, and we can go further. I feel like I am on the right track with my treatment program.

To me, that is everything. I know this video had a lot of data and information to absorb in just one sitting. But the more you know about NMOSD and treatments like ENSPRYNG, the more effective your conversations can be with your doctor. Working together, you can decide the best ways to move forward.

I hope you found this video informative and helpful. Check out all the other videos in the series relating to ENSPRYNG at www.enspryng.com. They’re a valuable resource you can view anytime. You can even watch them more than once as a refresher. Thanks for listening and stay tuned for Important Safety Information.

“Reducing the risk of relapse is something I think about every day.”

-Donna, diagnosed with NMOSD in 2013


ENSPRYNG patient, Donna

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. 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. 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, 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, call 1-844-NSPRYNG.

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