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atopic dermatitis

Realm Therapeutics shares halved after failure of Phase 2 study

Shares in the London-listed Realm Therapeutics plummeted on Monday after the company reported that a Phase II study of the experimental drug PR022 had failed to meet its primary endpoint in people with atopic dermatitis.

Shares in the company dropped in price by more than half after a randomized, double-blind, vehicle controlled clinical trial of 122 patients showed that PR022 showed no difference from vehicle.

NICE backs Sanofi’s new treatment for atopic dermatitis

NICE has published a positive Final Appraisal Determination FAD recommending dupilumab, in combination with topical corticosteroids, for use on the NHS in England for the treatment of moderate to severe atopic dermatitis in adults when they have not responded to at least one other systemic therapy, such as immunosuppressants.

Atopic dermatitis (also known as atopic eczema) is the most common form of eczema in the UK and approximately 1.5 million (3%) adults have atopic dermatitis.

NICE rejects Dupixent for atopic dermatitis on cost grounds, Sanofi responds

UK drug watchdog NCIE has issued draft guidance rejecting the routine use of Sanofi’s Dupixent (dupilumab) for the treatment of moderate-to-severe atopic dermatitis on the NHS in adults when systemic therapy is suitable, citing, as usual, cost-effectiveness concerns. A consultation period has been opened to dispute the decision, ending 24 April.

FDA approves first-ever atopic dermatitis biologic treatment

Sanofi and Regeneron’s Dupixent (dupilumab) has become the first biologic medicine to be approved by the FDA for the treatment of moderate-to-severe atopic dermatitis (AD), the most common form of eczema, in adults when topical prescription therapies are ineffective or inadvisable.

Pfizer’s next blockbuster given FDA approval

Pfizer announced that it had received approval for its eczema treatment, Eucrisa, for patients of two years of age and older. The treatment of mild to moderate atopic dermatitis (AD) is usually by a topical steroid but Pfizer’s is a new non-steroid treatment. Pfizer expects Eucrisa to achieve annual peak sales of $2 billion.

Pfizer announces strong Phase III results for atopic dermatitis drug

Pfizer (NYSE: PFE) has announced positive results from two pivotal Phase III studies for crisaborole in the treatment of mild to moderate atopic dermatitis.

Sanofi and Regeneron combo shows superiority in late-stage atopic dermatitis trials

Sanofi (NYSE: SNY) and Regeneron (NASDAQ: REGN) have announced positive results from a Phase III trial evaluating dupilumab in patients with moderate-to-severe atopic dermatitis.

Atopic dermatitis is a serious from of eczema which is characterised by itchy, inflamed skin that can be present on any part of the body. There are approximately 1.6 million people in the US alone who suffer from moderate-to-severe forms of the inflammatory disease.

Sanofi and Regeneron announce positive Phase III trial results for chronic skin disease treatment

Sanofi (NYSE: SNY) and Regeneron Pharmaceuticals (NASDAQ: REGN) have announced positive top line results for dupilumab in Phase III clinical trials for chronic inflammatory skin disease, atopic dermatitis.

This severe form of eczema affects 1-3% of adults worldwide, and an estimated 7-8 million adults in the US alone.

In the LIBERTY AD SOLO 1 and SOLO 2 clinical trials, treatment with dupilumab as monotherapy showed significantly improved measures of overall disease severity, skin clearing, itching, quality of life and mental health.

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