How big pharma benefit from its competitors

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https://www.nasdaq.com/articles/how-this-pharma-company-can-benefit-from-its-competitors-2021-06-20

How This Pharma Company Can Benefit From Its Competitors​

CONTRIBUTOR
Jeff Little The Motley Fool
PUBLISHED
JUN 20, 2021 5:11AM EDT

 

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The race is on among pharmaceutical companies to obtain approval from the U.S. Food and Drug Administration (FDA) for new products serving the atopic dermatitis (AD, otherwise known as severe and chronic eczema) market. One of those companies, Incyte (NASDAQ: INCY), is coming off successful phase 3 trials of its ruxolitinib cream, but is now facing challenges brought on by delays in FDA approval.

The company anticipated a ruling from the FDA in June of this year, but that has since been backed up until Sept. 21. This makes for the second FDA delay involving a drug from Incyte. In April, its collaborative effort with Eli Lilly, olumiant, also received a delay for approval in use as an AD treatment, with news now expected in late summer.

 

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Concerns about side effects​

This most recent delay is not necessarily Incyte's fault. The FDA has recently placed increased focus on the potential side effects of JAK inhibitors such as ruxolitinib, which belong to a family of treatments called DMARDs (disease-modifying antirheumatic drugs). JAK inhibitors are used to help reduce inflammation by limiting an overactive immune system, but a weakened immune system can have serious side effects -- such as cancerous tumors, anemia, tuberculosis, and shingles.

A lengthening lead​

As a result of all this, go-to-market dates for JAK inhibitor-based products from Incyte, Eli Lilly (olumiant), Pfizer (abrocitinib), and AbbVie (rinvoq) as treatments for ADcould all be affected. That, in turn, could provide an excellent opportunity for market-leading Dupixent, the already approved AD cream from Sanofi (NASDAQ: SNY) and Regeneron (NASDAQ: REGN), to potentially lengthen its lead over the competition.

 

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The key difference for Dupixent in avoiding FDA safety scrutiny is that it is not a JAK inhibitor. Dupixent is an IL-4 and IL-13 inhibitor, and it does not have the safety risks associated with JAK inhibitors.

Dupixent, offered as both a cream for AD and an injectable for asthma, was responsible for more than $1.25 billion for Sanofi during the first quarter. That marked a 45% quarterly gain year over year, including a 16% gain in prescriptions new to the brand. The company stated during its first-quarter results that high demand was generated from the AD market in adults, adolescents, and children ages 6-11. This is an important takeaway, because AD is common in children, at a rate of 10.7% in the U.S., with 33% of those being considered moderate to severe cases.

 

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On top of those strong first-quarter results and competitor delays, Sanofi is making the most of the FDA delays of competitors' products in an attempt to pull away from the pack. According to data from real-time TV ad tracker iSpot.tv, Dupixent took over the top spot in pharma TV ad spending during the month of May. During the month, Sanofi and Regeneron spent $24 million on 10 spots, up from $20 million in April. Of the 10 ad spots, six were dedicated to AD, while four were focused on asthma.

 

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What's at stake?​

The atopic dermatitis market comprises an estimated 18 million people, and a total of 31 million have some form of eczema. There are treatments such as Dupixent, but currently no known cure. As Dupixent continues its reign, and competitors await FDA rulings, there is a potential $34 billion market value to be had by 2026, based on an estimated compound annual growth rate between 7.8% to 10.4%

 

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Right now it looks as though the collaboration between Sanofi and Regeneron is on its way to victory in this space, and the AD market could be a gold mine in the near future. However, if favorable FDA rulings come through in the third quarter, the AD cream space could become crowded quickly. If Incyte gets good news and is the first to market with its product, I would consider a small investment, but not before then. If the FDA denies approvals or requires additional support data, Sanofi might be the smarter play.

 

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Is Dupixent a steroid?

DUPIXENT is a form of medicine called a biologic and taken by injection under the skin (subcutaneous injection). DUPIXENT Is not a topical steroid or cream, but can be used with or without other topical steroids.

 

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Does Dupixent cure eczema?

Dupixent (dupilumab) is not a cure for eczema; however, it does effectively reduce symptoms in the majority of people prescribed it, such as: Itching. The appearance of the rash. The frequency of AD flares.

 

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https://www.medicalnewstoday.com/articles/326617#What-is-Dupixent?

What is Dupixent?​

Dupixent (dupilumab) is a brand-name prescription medication. It’s used to treat the following conditions:

• Moderate to severe eczema(atopic dermatitis). It’s prescribed for adults and for children ages 12 years and older when symptoms can’t be controlled with topical prescription drugs (or when those drugs should not be used).
• Moderate to severe asthma.It’s prescribed for adults and for children ages 12 years and older with eosinophilic asthma or oral corticosteroid-dependent asthma. It’s used as an add-on maintenance treatment. Rescue inhalerscan still be used as needed for asthma attacks or symptoms such as trouble breathing. Dupixent should never be used to treat a sudden asthma attack.
• Chronic rhinosinusitis with nasal polyps. It’s prescribed for adults whose symptoms are not well controlled. It’s used as an add-on to maintenance treatment.

Dupixent belongs to a class of medications called monoclonal antibodies. These drugs work on a very specific part of your immune system.

Dupixent comes in a single-dose prefilled syringe. It’s given as a subcutaneous injection (under your skin). Dupixent comes in two doses: a 200-mg/1.14-mL solution and a 300-mg/2-mL solution.

You can receive Dupixent at your doctor’s office or give yourself injections at home after you learn how. You and your doctor can talk about the best option for you.

For treating moderate to severe eczema and moderate to severe asthma, the first dose is two injections in different areas of your body. After that, you only need one injection every other week. For chronic rhinosinusitis with nasal polyps, treatment is one injection every other week.

 

[eatshitndie]

are you scratching your butt frequently because of eczema?

 

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Effectiveness​

Clinical trials have shown Dupixent to be effective in treating eczema, asthma, and chronic rhinosinusitis with nasal polyps.

• For eczema: In a clinical trialfor teenagers with moderate to severe eczema, 24% of people saw clearer skin and 37% of people had less itching within a 16-week period. In adults with eczema, clinical trials showed that almost half of people had a 75% improvement in their skin. Between 36% to 39% of people had clear or almost-clear skin at the end of a 16-week period.
• For asthma: In people with asthma ages 12 years and older, clinical trials showed that Dupixent helped prevent severe asthma attacks. It improved people’s breathing, and they didn’t have to use oral corticosteroids as often to relieve asthma symptoms. Oral corticosteroids are medications such as prednisone that are used to treat inflammation.
• For chronic rhinosinusitis with nasal polyps: In a 24-week clinical trial, people taking Dupixent saw about a 51% to 59% improvement in nasal congestion. This is compared to a 16% to 18% improvement in people taking a placebo (a treatment without an active drug). Also, 52% of people saw improvement in their sense of smell. Reduced ability to smell is a common side effect of nasal polyps.

 

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FDA approval​

Dupixent was first approved by the Food and Drug Administration (FDA) in 2017 to treat eczema in adults.

In 2018, it was approved as an add-on maintenance therapy to treat moderate to severe asthma that’s classified as eosinophilic or corticosteroid-dependent in adults and in children ages 12 years and older.

In 2019, Dupixent was approved to treat moderate to severe eczema in children ages 12 years and older with symptoms that can’t be controlled topical prescriptions (or when topical treatments should not be used). Also in 2019, Dupixent was approved as add-on maintenance therapy to treat chronic rhinosinusitis with nasal polyps in adults.

 

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are you scratching your butt frequently because of eczema?

What rubbish you talking? I have eczema flare up on my hands not butt.

 

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I am 0.01% Singaporean with illness from eczema to sleep apnea that all have no cure.

 

[jw5]

What rubbish you talking? I have eczema flare up on my hands not butt.

LOL......................................

 

[eatshitndie]

What rubbish you talking? I have eczema flare up on my hands not butt.

oh dear, need to be careful not being too touchy. everywhere anywhere can cause allergies and inflamation. pang sai wipe arse also can get flare ups, especially with cheap made in prc toilet paper.

 

[bart12]

I am 0.01% Singaporean with illness from eczema to sleep apnea that all have no cure.

Karma??

 

[jw5]

Karma??

Kanina

 

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Karma??

What rubbish are you talking? For you evil filthy Malaysian Indian liar son of whore is called karma, for me is called injustice. Pui!