Please scroll down for updated information on Dupilumab
Atopic dermatitis (eczema) patients may have a new medication on the horizon, Dupilumab. Regeneron Pharmaceuticals has partnered with Sanofi to develop this new medication which is currently under clinical trials. There is no current brand or trade name for Dupilumab. (See below for update, the trade or brand name is now, Dupixent.) This would be the first monoclonal antibody approved for atopic dermatitis (eczema). Recently for asthma, another monoclonal antibody was approved, Nucala which came after Xolair.
For atopic dermatitis (eczema), there has not been any new medications for a number of years since Elidel (pimecrolimus) and Protopic (tacrolimus) were approved, but many patients have been turned off by its black box warnings. The current treatment approach for atopic dermatitis (eczema) is Eczema Treatment.
The yet to be named Dupilumab works in a novel way. Data from early-stage studies suggest that TH 2 cytokines, IL-4 and IL-13 are drivers of atopic dermatitis. There has been marked improvement after treatment with dupilumab, a fully human monoclonal antibody that blocks both pathways. A recent study was done to assess the efficacy and safety of several dose regimens of dupilumab for atopic dermatitis (300mg once a week, 300mg every 2 weeks, 200mg every 2 weeks, 300mg every 4 weeks, 100mg every 4 weeks) in adults with moderate to severe atopic dermatitis (eczema) whose symptoms were inadequately controlled by topical treatments and who had severe eczema scores on an eczema index scale.
The study determined that all of the patients with atopic dermatitis (eczema) improved favorably with dupilumab in a dose-dependent manner versus placebo, without significant safety concerns.
Regeneron and Sanofi have high hopes for dupilumab assuming it gets FDA approval. Currently patients with moderate to severe atopic dermatitis do not have any treatments that treat patients from the “inside”. In atopic dermatitis (eczema), evidence suggests that nonlesional skin is not normal skin due to persistent subclinical inflammation throughout the body. Skin findings in eczema show barrier defects and weakening, increased thickness and ongoing inflammation. Inflammation is the source of lesions and itching. Besides atopic dermatitis (eczema), other atopic diseases that could potentially be treated by dupilumab are asthma, chronic sinusitis with nasal polyps, eosinophilic esophagitis and allergic rhinitis, as they share the IL-4 and IL-13 pathways which lead to inflammatory processes.
We will keep you updated as Regeneron and Sanofi move dupilumab through its FDA trials. There is no launch date yet on dupilumab, but it is on a fast track for FDA approval, please check back up with us later to get a release date. As of January 2016, Regeneron completed a Phase 3 trial for dupilumab, we are awaiting its results. For information on how many phases are needed, you can read more about it here, New Asthma Medications. Dupilumab will most likely be approved sometime in 2017 according to Regeneron and available in 2018, maybe even 2019 at the latest.
There is no price yet on dupilumab, but if we go by the cost of the other biologic monoclonal antibodies (i.e. Xolair, Nucala), dupilumab may cost a couple of thousand dollars a month. Some analysts expect it to cost approximately $30,000 a year. Many patients with atopic dermatitis do not find relief with the medications out there currently for eczema, and we hope dupilumab gets approved soon in the near future and target the IL-4 and IL-13 pathways.
Another monoclonal antibody that is being investigated these days is lebrikizumab, this works in a similar way to dupilumab. Lebrikizumab
Update 4/1/2106: Regeneron and Sanofi announced today the results of their Phase 3 trials for Dupilumab. They recruited 1,379 adults with moderate to severe eczema whose condition was not controlled by topical medications. They had 2 identical trials, patients either received dupilumab or placebo. Both trials had near identical results. Approximately 70% of patients receiving the dupilumab every week or every 2 weeks saw some improvement, and approximately 37% patients showed clearing or near-clearing of skin lesions. The patients on the medication did significantly better than the patients receiving placebo. The safety data on dupilumab was actually better than the placebo arm in these trials. The study was done on adults 18 years and older, pediatric studies are ongoing as well, for children between 6-18 years old, it is currently in stage 2 trials in Europe and Canada.
The company plans to present detailed results at some point in the near future and will submit an application to the FDA later this year according the president for global research and development at Sanofi. Regeneron and Sanofi will try and get it approved as quickly as possible, some are speculating that it may be available in little over 1 year, as there is a great need for medications to treat atopic dermatitis (eczema). We will continually update this site regarding the approval process and expected launch date.
A recent study was published in the Lancet looking into dupilumab for asthma, the conclusions of the study showed.
Dupilumab increased lung function and reduced severe exacerbations in patients with uncontrolled persistent asthma irrespective of baseline eosinophil count and had a favourable safety profile, and hence in addition to inhaled corticosteroids plus long-acting β2-agonist therapy could improve the lives of patients with uncontrolled persistent asthma compared with standard therapy alone.
It looks like dupilumab will get other indications besides atopic dermatitis alone. Most likely it will be approved for eczema first followed by asthma.
Dupilumab therapy in patients with Nasal Polyposis and Chronic Sinusitis (Update July 2016)
A recent study in JAMA studied the effect of subcutaneous dupilumab on nasal polyp burden in patients with chronic sinusitis and nasal polyps.
Chronic rhinosinusitis consists of persistent inflammation of the paranasal sinuses lasting longer than 8 to 12 weeks. Nasal polyps is a common finding and it is associated with prolonged inflammation in the paranasal sinuses and often coexists with asthma or aspirin sensitivity. Treatment of chronic rhinosinusitis usually consists of corticosteroids, antibiotics, aspirin desensitization in some instances or surgery in severe cases. In the past we discussed potential treatment options on the horizon. Potential new Nasal Polyps Treatment option
Previous reports have documented efficacy of dupilumab on atopic dermatitis and asthma. In this study, it was given as a 600 mg loading dose, followed by 15 weekly doses of 300 mg for 15 weeks. The primary efficacy outcome was the mean change in bilateral endoscopic nasal polyp score from baseline to week 16.
Results: The mean reduction in nasal polyp score was significantly greater with dupilumab plus Nasonex than with placebo plus Nasonex, a difference was seen as early as 4 weeks and continued until the end of treatment at 16 weeks. Improvement was seen among 70% of dupilumab group and 20% in the placebo group. In addition, those in the dupilumab group reported a significant improvement in rhinorrhea, nasal congestion and a sense of smell. Also, patients with asthma showed significant improvements in their spirometry and symptom scores. Sustained improvement was seen further after the 16 week follow up off the dupilumab treatment. No serious adverse events were seen.
Conclusion: Dupilumab may be a novel treatment for patients with nasal polyps and chronic rhinosinusitis refractory to topical corticosteroid therapy. Dupilumab may be particularly useful for nasal polyp disease with co-morbid asthma. Long term efficacy and safety data are still needed. This study is exciting news, not only does it seem to work for atopic dermatitis and asthma, it seems to work for nasal polyps and chronic rhinosinusitis as well. Hopefully FDA approval will happen in the near future, please check back with us for further updates.
Update July 28, 2016-Some reports will have dupilumab available in less than a year from now.
“Since dupilumab received breakthrough therapy designation from the FDA, we expect a fast review process, with potential approval and subsequent launch in early 2017,” noted Leerink’s Geoffrey Porges. Phase 3 long term studies showed 4 out of 10 patients receiving the drug reported complete or near complete clearing of skin lesions. 64% reported 75% clearing of eczema.
Because of its breakthrough status designation from the FDA, dupilumab will most likely go under a fast review process and be available sooner than expected, as Mr. Porges noted, a possible launch date will be in early 2017.
Dupilumab efficacy and safety in adults with uncontrolled asthma (Update August 2016)
In a study published in Lancet 2016, the authors aimed to assess the efficacy and safety of dupilumab as add-on therapy in patients with uncontrolled persistent asthma receiving medium to high dose inhaled corticosteroids plus a long term Beta agonist. Patients were randomly assigned to receive 200 or 300 mg of subcutaneous dupilumab every 2 or 4 weeks or placebo over a 6 month period.
The authors determined that dupilumab increased lung function and reduced severe exacerbations in patients with uncontrolled persistent asthma, irrespective of baseline eosinophil count and had a favorable safety profile. Therefore in addition to inhaled corticosteroids and a long term Beta-2 agonist therapy, dupilumab could improve the lives of patients with uncontrolled persistent asthma compared with standard therapy alone. Sally Wenzel, the first author in the study said “This study is the first to suggest that some Type-2 immune pathway directed treatments may work in a broader population than initially believed. Better biomarkers for these potential responder patients, beyond blood eosinophils, are likely needed.”
Update October 5, 2016
Another study was released by Regeneron and Sanofi, and the results are fantastic for atopic dermatitis sufferers. Nearly 40 percent of participants getting the drug saw all or almost all of their rash disappear. For some, relief was almost instantaneous. The drug’s brand name will be Dupixent. The FDA has given the drug breakthrough status. The FDA expects to rule on Dupixent by March 29, 2017. Dupixent’s price will be “consistent with the value of the drug.” according to the president and CSO at Regeneron, Dr. George Yancopoulos. It will be given every 2 weeks. As discussed previously, if Dupixent is priced in line with other biologics such as Nucala, Xolair or Cinqair, the cost will be approximately $2500/month. But we won’t know the official amount until it is actually released on the market. Dupilumab, trade name Dupixent, may even cost more because it is first in its class and there are almost no other alternative medications for eczema if topical creams do not work.
Update January 11, 2017
Dupilumab (Dupixent) was on course for a release date in March 2017, but there may be a hang up now. The Sanofi plant which will manufacture the medication has been cited by the FDA with a form 483.
The FDA did not have any problems with the safety or effectiveness of the drug, but they wanted some plant issues resolved. Stay tuned for more updates about the expected launch date of Dupilumab.
Update March 21, 2017
More studies have come out showing dupilumab is superior to placebo in ameliorating symptoms of atopic dermatitis. Published in the New England Journal of Medicine, in the SOLO trials, Dupilumab was associated with a reduction in itching and symptoms of anxiety or depression and improvement in quality of life. In 2 trials there was an improvement from baseline at week 16 in significantly more patients who received dupilumab than in patients who received placebo. Patients either received Dupixent every week or every other week.
Update March 23, 2017
A decision by the FDA is expected next week on Dupixent. Yesterday, Sanofi and Regeneron sued Amgen to protect the patent on dupilumab. Amgen tried to develop an an anti IL-4/13 asthma medication in the 2000’s and each side claims they have a patent on it. The decision to sue Amgen was pre-emptive as Amgen was planning to sue Sanofi/Regeneron. It remains to be seen if this will affect the availability of Dupixent. Praluent, a cholesterol drug was also part of a patent dispute between the 3 companies and it was allowed to remain on the market during its appeals process even though it was found to impinge on Amgen’s patent of a similar drug, Repatha.
Update March 28, 2017-Dupixent gets FDA Approval
Sanofi and Regeneron have announced today that Dupixent (dupilumab) has won FDA approval. It will be the first biologic medication for adults to treat moderate to severe atopic dermatitis whose disease is not adequately controlled by topical medications or when those therapies are not advisable. Dupixent will come in pre-filled syringes and it can be self administered as a subcutaneous injection every other week after an initial loading dose. It will be 300mg/2ml vial that will be injected every 2 weeks and it will need to be refrigerated. Dupixent is expected to be available later in the week. The wholesale cost of Dupixent is $37,000 a year or about $3000/month. Actual costs may be lower to patients and payers. Sanofi and Regeneron are launching a patient support system called Dupixent MyWay to help eligible patients who are uninsured, lack coverage or need special assistance for out of pocket costs. Patients who have asthma who start taking dupilumab, should not adjust their asthma medications. Dupilumab is still being investigated for the treatment of asthma and its efficacy still has not been fully determined.
Two studies are currently underway for the treatment of eczema in pediatrics. One is for children aged 6 months to 11 years and the other is 12-17 year olds. The safety and effectiveness of dupilumab is being tested in those age groups.