When Was Dupixent Approved For Asthma

Fda To Review Sanofi/regenerons Dupixent In Children With Uncontrolled Asthma

The US Food and Drug Administration will review Sanofi/Regenerons Dupixent as an add-on treatment for children aged six to 11 years with uncontrolled moderate-to-severe asthma.

Currently, Dupixent is approved as an add-on treatment for patients with uncontrolled moderate-to-severe asthma who are aged 12 years and older, and who have elevated eosinophils or oral corticosteroid dependent asthma.

Dupixent is a monoclonal antibody that inhibits interleukin-4 and interleukin-13 key drivers of the type 2 inflammation that plays a major role in asthma, as well as chronic rhinosinusitis with nasal polyposis , atopic dermatitis and eosinophilic esophagitis.

The supplemental biologics license application for Dupixent is supported by data that includes Phase III results evaluating Dupixent in addition to standard-of-care maintenance therapy in children with moderate-to-severe asthma with type 2 inflammation.

In the trial, Dupixent was able to significantly reduce severe asthma attacks and also rapidly improve lung function within two weeks in children aged six to 11 years.

The target action date for the FDAs decision on Dupixent in this indication is 21 October 2021.

Sanofi/Regeneron are also planning an EU regulatory submission for Dupixent in this patient population in Q1 20201.

What If I Miss A Dose

If you miss your dose of Dupixent, take the dose within 7 days of your missed dose. If you forget to take it within 7 days, skip that dose and wait until the next dose youre supposed to take.

To help make sure that you dont miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Does Dupixent Treat Food Allergies

No, Dupixent is not used to treat food allergies at this time. While its currently being tested as a treatment for children with peanut allergies, its not approved for this use.

Dupixent is being tested along with another medication, called AR101, thats specifically used for peanut allergies. The idea is that using the combination of AR101 and Dupixent could allow childrens immune systems to learn not to react to peanuts. This would mean that children with severe peanut allergies who were exposed to peanuts wouldnt have a life-threatening allergic reaction.

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Does Dupixent Cause Hair Loss

People using Dupixent in clinical studies didnt report hair loss as a side effect.

But since Dupixent was approved, there have been rare reports of people experiencing hair loss after using the drug.

On the other hand, Dupixent has been found to reduce hair loss in some people. Research has looked at people with atopic dermatitis, and a condition called alopecia areata . Dupixent reduced both hair loss and atopic dermatitis. Because of this information, the drug is being studied to see if it can treat hair loss.

At present, its not known if Dupixent can cause hair loss or if the drug may treat hair loss. If youd like to learn more about Dupixent and hair loss, talk with your doctor or pharmacist.

Fda Approves Asthma Indication For Dupixent

TARRYTOWN, N.Y.

Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype

Only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype

Only asthma biologic that offers patient self-administration at home

Only asthma biologic also approved for adult patients with moderate-to-severe atopic dermatitis, a Type 2 inflammatory disease driven by the IL-4 and IL-13 pathway

In clinical trials, Dupixent reduced severe exacerbations and oral corticosteroid use and improved lung function

Regeneron Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration has approved Dupixent® as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Dupixent inhibits the overactive signaling of interleukin-4 and interleukin-13 , two key proteins that contribute to the Type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers including fractional exhaled nitric oxide , immunoglobulin E and eotaxin-3 .

In the asthma clinical trials, the adverse reactions that occurred with Dupixent at a rate of at least 1% and more frequently than the respective comparator were injection site reactions, sore throat, and an increase in the number of eosinophils, a type of white blood cell, in the blood.

INDICATIONS

Sanofi

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Fda Approves Dupixent For Treatment Of Asthma

The Asthma and Allergy Foundation of America;is sharing this press release from;Sanofi and Regeneron to bring you the latest news quickly.

PARIS and TARRYTOWN, NY – October 19, 2018;/PRNewswire/ –

FDA approves asthma indication for Dupixent®;

• Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype
• Only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype
• Only asthma biologic that offers patient self-administration at home
• Only asthma biologic also approved for adult patients with moderate-to-severe atopic dermatitis, a Type 2 inflammatory disease driven by the IL-4 and IL-13 pathway
• In clinical trials, Dupixent reduced severe exacerbations and oral corticosteroid use and improved lung function

The U.S. Food and Drug Administration has approved Dupixent®; as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.;

Dupixent inhibits the overactive signaling of interleukin-4 and interleukin-13 , two key proteins that contribute to the Type 2 inflammation that may underlie moderate-to-severe asthma. This effect is associated with the reduction of inflammatory biomarkers including fractional exhaled nitric oxide , immunoglobulin E and eotaxin-3 .

For people with asthma, Dupixent comes in two doses given every other week at different injection sites after an initial loading dose.

Data Collection And Assessment

Demographic , asthma characteristics and comorbidities were collected at baseline. Number of exacerbations, pulmonary function tests, blood eosinophils count, fractional exhaled nitric oxide , Asthma Control Test score,12,13 and daily OCSs intake were assessed before starting the therapy with dupilumab and after 3, 6, and 12 months of treatment. Asthma exacerbations were defined as a disease worsening requiring 3 days of treatment with OCSs .14 One patient had 2 exacerbations treated with cycles of corticosteroids < 7 days from each other and were considered as the same exacerbation. Lung function tests were performed according to ERS/ATS guidelines.15

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How Long Does It Take To Work

Dupixent begins to work after the first injection. However, it may take a few weeks before you notice an improvement in symptoms.

In a clinical study, more than 36% of adults with eczema had relief from itching in 16 weeks or less while taking Dupixent. In children ages 12 to 17 years old, 37% had itching relief in 16 weeks.

You should continue treatment for at least 16 weeks to determine if Dupixent works for you. If your eczema, asthma, or chronic rhinosinusitis with nasal polyps isnt responding or improving after 16 weeks, talk with your doctor. You can discuss whether you should keep taking Dupixent or switch to another treatment.

Here are answers to some frequently asked questions about Dupixent.

Dupixent And Other Medications

Below is a list of medications that can interact with Dupixent. This list does not contain all drugs that may interact with Dupixent.

Before taking Dupixent, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Live vaccines

Its important not to get any live vaccines while taking Dupixent. For live vaccines, youre injected with a small amount of a virus so your body can learn to fight it. Dupixent may weaken your immune system, so a live vaccine could make you sick.

Before starting Dupixent, talk to your doctor or pharmacist about any vaccines you may need. You should get any live vaccines you need before you start taking Dupixent.

Live vaccines you should avoid when taking Dupixent include:

• measles, mumps, rubella

• prickling or tingling feeling like pins and needles in your arms or legs
• fever

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Should I Expect To Gain Weight When Taking Dupixent

Its unlikely youll gain weight as a side effect from using Dupixent. People using the drug in its original clinical studies didnt report weight gain.

Since the drug was approved, a very small study found a possible link between weight gain and Dupixent treatment in people with atopic dermatitis . But more research is needed to determine whether Dupixent or a different factor caused the weight gain in the people.

Some other drugs that treat the same conditions Dupixent is prescribed for can cause weight gain. These other drugs include corticosteroids such as prednisone .

If you have questions or concerns about weight gain or your Dupixent treatment, talk with your doctor.

Will I Be Able To Get Vaccines While Im Using Dupixent

You shouldnt get any live vaccines while taking Dupixent. For live vaccines, youre injected with a small amount of a virus so your body can learn to fight it. You shouldnt get these vaccines while using Dupixent because the drug may weaken your immune system. If this happens, your body wont be able to properly fight the vaccine, and it may make you sick.

Talk to your doctor or pharmacist about what vaccines you may need. Its best to get any needed vaccines before starting Dupixent.

Live vaccines you should avoid while taking Dupixent include:

• measles, mumps, rubella
• typhoid

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Dupilumab Dose For Asthma

Question:

Dupilumab dose for asthma: when do you use 200 mg vs. 300 mg?

Answer:

Dupilumab is indicated as an add-on maintenance treatment for moderate-to-severe asthma in patients aged 12 years and older with eosinophilic phenotype or PO corticosteroid dependent asthma.

Dupilumab dose for asthma:- 400 mg SC once, then 200 mg q2weeks, OR- 600 mg SC once, then 300 mg q2weeks

For patients with PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis , administer 600 mg initial dose then 300 mg q2weeks.

The answer is:- 200 mg maintenance dose is for moderate-to-severe asthma with eosinophilic phenotype- 300 mg maintenance dose is for PO corticosteroid-dependent asthma or comorbid moderate-to-severe atopic dermatitis

You could use 300 mg for moderate-to-severe asthma with eosinophilic phenotype, but the NEJM graph here shows that the doses response curves run parallel to each other and there is not benefit of the higher dose:

The Chief Scientific Officer of Regeneron regards these as 2 separate groups: “Dupixent is now approved in the U.S. for two important groups of uncontrolled asthma patients those who are moderate-to-severe with an eosinophilic phenotype or those with oral corticosteroid-dependent asthma”.

Dupixent is expected to be approved for chronic sinusitis at the 300 mg dose.

References:

Model Suggests Body Weight Affects Dupilumab Pharmacokinetics In Patients With Asthma

Although body weight affected pharmacokinetics, the investigators said dosing adjustments based on weight were not warranted.

A new report shows the pharmacokinetic properties of Dupixent are similar in patients with asthma and atopic dermatitis , and suggests body weight is the major factor affecting the drugs variability among patients.

The findings, based on a pharmacokinetic model developed by investigators at Sanofi and Regeneron, were recently published in CPT: Pharmacometrics & Systems Pharmacology.

The authors explained that dupilumab is a recombinant human immunoglobulin-G4 monoclonal antibody that binds to the shared receptor component for interleukins 4 and 13, which are the key drivers of type 2 inflammation in asthma and similar diseases like AD. The FDA has approved dupilumab for teenagers and adults with eosinophilic phenotype or oral corticosteroiddependent asthma. The drug is also approved in Europe for certain patients with severe asthma.

The model was a helpful tool to predict the impact of different dosing regimens or loading dose on the dupilumab profile and to optimize the study design for dosing regimen in other asthma studies, the authors wrote.

The model showed no statistically significant difference between the pharmacokinetics of dupilumab in patients with asthma compared with healthy controls.

And although weight was found to impact the pharmacokinetics, the authors said weight-based dose adjustments were unnecessary.

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Will I Have Withdrawal Symptoms If I Stop Using Dupixent

Its not likely that youll experience withdrawal symptoms when you stop taking Dupixent.

However, if you take steroid pills such as prednisone to control your symptoms, you may have withdrawal symptoms if you stop taking those. Symptoms of withdrawal from suddenly stopping a steroid includes weakness, nausea, vomiting, and feeling tired.

You shouldnt stop taking steroid medications abruptly or without talking to your doctor. Its best to slowly lower your dose of steroids before stopping entirely.

Pregnancy And Breastfeeding While Taking Dupixent

Heres some information about pregnancy, breastfeeding, and Dupixent treatment.

Pregnancy. Its not known whether its safe to use Dupixent while pregnant. If you and your doctor agree that using the medication is the best option for you while pregnant, you may want to join a pregnancy registry. The registry monitors the health of people who use Dupixent during pregnancy. To learn more or sign up, call 877-311-8972 or visit the registry website. You can also talk with your doctor.

Breastfeeding. Its not known whether Dupixent passes into human breast milk or is safe to use while breastfeeding. Your doctor can advise you on the pros and cons of the medication. They can also recommend healthy feeding options for your child.

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How To Use Dupixent

You can inject the Dupixent pre-filled syringe into your thigh or stomach, except for the 2 inches around your belly button. If a caregiver injects the dose, they can also use the outer area of the upper arm.

Choose a different site each time you inject Dupixent. Do not inject into skin that is tender, damaged, bruised or scarred.

Lay the Dupixent Syringe on a flat surface and let it naturally warm to room temperature for at least 30 minutes or 45 minutes . Do not heat the syringe or place in direct sunlight.

• Before injection, wash your hands well with soap and water. Pinch a fold of skin at the injection site . Insert the needle completely into the fold of the skin at about a;45° angle.
• Relax the pinch. Push the plunger rod down slowly and steadily as far as it will go until the Dupixent Syringe is empty. Lift your thumb to release the plunger rod until the needle is covered by the needle shield and then remove the syringe from the injection site.
• Dispose of the syringe as directed.

What are the side effects of Dupixent ?

eye pain or discomfort

watery eyes

pain, swelling, burning, or irritation where an injection was given.

blood vessel inflammation

eye redness or itching, puffy eyelids

stomach pain, nausea, vomiting

Response According To Blood Eosinophil Count And Feno Values At Baseline

To evaluate the clinical response according to the baseline blood eosinophil count, we compared patients with < 300 cells/L vs 300 cells/L . As shown in Table 3, ACT score , FEV1 and OCSs use were comparable in both groups after 12 months. Similarly, patients with a FeNO value < 25 ppb or 25 ppb showed no statistically significant differences at the end of the follow-up.

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What Side Effects Can I Expect When Using Dupixent For Asthma

More common side effects in people taking Dupixent for asthma include:

• reactions where the drug is injected, such as pain and swelling
• throat pain or soreness
• high levels of white blood cells called eosinophils*

For a full list of side effects Dupixent may cause in people with asthma, you can view the drugs prescribing information. You can also ask your doctor or pharmacist.

* For more information, see Eosinophilic conditions in the Side effect specifics section below.

Dupixent For Other Conditions

You may wonder if Dupixent is used for certain other conditions in addition to those listed above. Here we discuss some conditions that Dupixent may or may not be used to treat.

Dupixent for alopecia

Dupixent is currently in clinical trials to see if its effective in treating alopecia. If you have alopecia, your immune system attacks your hair follicles, causing hair loss. Alopecia ranges from patches of hair loss to total hair loss.

Some people with alopecia taking Dupixent for eczema have had their hair start to regrow while taking the drug.

Dupixent for cancer

Dupixent hasnt been shown to be effective in treating cancer. Other medications used to treat asthma that are similar to Dupixent, such as Xolair, may increase the risk of developing cancer.

Dupixent can help treat nasal polyps in people with chronic rhinosinusitis with nasal polyps. However, these nasal growths are not cancerous.

Dupixent for psoriasis

Dupixent is not approved to treat psoriasis, a condition that causes thick, red patches to appear on the skin. Eczema may appear to be similar to psoriasis. However, eczema is usually much itchier than psoriasis.

Your doctor can determine if you have eczema or psoriasis and if Dupixent is the right treatment for you.

Dupixent for dyshidrotic eczema

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More Common Side Effects

The more common side effects of Dupixent can include:

• injection site reactions
• gastritis
• eosinophilia

* Occurs only if youve been exposed to the herpes virus

Most of these side effects may go away within a few days or a couple of weeks. If theyre more severe or dont go away, talk with your doctor or pharmacist.