New atopic dermatitis drug approved - Crisaborole (Eucrisa) phosphodiesterase-4 inhibitor, applied topically twice daily

The FDA approved crisaborole (Eucrisa) as a treatment for eczema (atopic dermatitis) in patients aged 2 years and older in December 2016. The drug is a phosphodiesterase-4 inhibitor, applied topically twice daily.

What is crisaborole?

Crisaborole is a boron-based, small-molecule, topical phosphodiesterase-4 inhibitor. Chemically, crisaborole is a phenoxybenoxaborole. It contains a boron atom that helps penetrate the skin and is essential for its binding activity.

How effective is crisaborole?

Two trials with 1,500 patients showed that crisaborole treatment was better than placebo in achieving the primary endpoint, which was skin clearance or near clearance plus at least a two-point improvement in global assessment of disease severity after 4 weeks.

32% of patients receiving crisaborole achieved this endpoint, versus about 25% of the placebo groups.

Despite the strong placebo effect noted in these trials, crisaborole appears a promising nonsteroidal topical treatment for mild to moderate atopic dermatitis. Studies of longer duration than four weeks are needed to evaluate its long-term efficacy and safety.



Atopic Dermatitis Treatment - Illustrated (click to enlarge the image).

What are the side effects of crisaborole?

Adverse events were generally mild and included burning or stinging at the application site. Serious side effects of Eucrisa include hypersensitivity reactions.

Local Adverse Reactions range for 1% to 10%. Application site pain was reported in 4% of patients. Fewer than 1% had hypersensitivity reaction, urticaria. Hypersensitivity reactions have been reported, including contact urticaria. Severe pruritus, swelling, or erythema (at the application site or at a distant site) may be indicative of hypersensitivity. Discontinue immediately for signs of hypersensitivity.

Crisaborole is also under development by Anacor Pharmaceuticals for the topical treatment of psoriasis.

How much is the cost of crisaborole?

Eucrisa is a 2% ointment, marketed by Pfizer More info is available here: http://www.myeucrisa.com/

No pricing info is available as of 01/2017.

Hope on the horizon: monoclonal antibody dupilumab

Pfizer will have some heavyweight competition in the field of atopic dermatitis. Regeneron and Sanofi have lined up impressive Phase III data for the monoclonal antibody dupilumab, analysts are projecting a multibillion-dollar peak sales figure for the drug.

References:

Novel Eczema Drug OK'd - Medpage Today http://buff.ly/2ikBGe4
UpToDate, 2017, https://www.uptodate.com/contents/treatment-of-atopic-dermatitis-eczema
Pfizer racks up an FDA approval for eczema blockbuster hopeful crisaborole - EndPts http://buff.ly/2j84TGj

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