Pfizer receives FDA approval for Eucrisa (crisaborole), a novel non-steroidal topical ointment for mild to moderate atopic dermatitis (eczema).
Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Eucrisa (crisaborole) ointment 2%, a novel non-steroidal topical phosphodieterase-4 (PDE-4) inhibitor for the treatment of mild to moderate atopic dermatitis (AD) in patients two years of age and older.1
AD, often called eczema, is a chronic condition impacting nearly 18 million children and adults in the United States.2 Approximately 90 percent of people living with AD have the mild to moderate form of the condition.3
“The approval of Eucrisa is great news for the children and adults suffering from mild to moderate eczema, a community that has not had a new prescription treatment for more than 10 years,” said Albert Bourla, group president, Pfizer Innovative Health. “This is also an important milestone for Pfizer as we continue to build on our heritage in inflammation and immunology by offering innovative treatment options to patients who need them.”
Eucrisa is the first and only non-steroidal topical monotherapy that inhibits the PDE-4 enzyme in the skin. Overactive PDE-4 has been shown to contribute to the signs and symptoms of AD.4 The specific mechanism of action of crisaborole in AD is not well defined.1
“I’m delighted to have a new option for my patients with mild to moderate atopic dermatitis,” said Amy Paller, M.D., Walter J. Hamlin Professor and chair of dermatology, professor of pediatrics, Northwestern University Feinberg School of Medicine, a clinical trial investigator. “The results seen in these pivotal Phase 3 studies show the efficacy and safety of Eucrisa as a steroid-free treatment option for people as young as two living with mild to moderate atopic dermatitis.”
The approval of Eucrisa is based on a clinical development program including the results of two large, identical, multicenter, randomized, double-blind, parallel-group, vehicle- controlled (non-medicated ointment) trials (Trials 1 and 2) that treated 1,522 patients with mild to moderate AD between the ages of two and 79.1 At baseline, 38.5% of the subjects had an Investigator’s Static Global Assessment (ISGA) score of 2 (mild), and 61.5% had an ISGA score of 3 (moderate). The ISGA score includes erythema (redness), induration (hardening)/papulation (formation of papules), and oozing/crusting on a severity scale of 0 to 4.
In both trials, subjects were randomized 2:1 to receive Eucrisa or vehicle (non-medicated ointment) applied to skin with signs and symptoms of AD twice daily for 28 days.1 The primary efficacy endpoint was success in ISGA at day 29, defined as the proportion of patients achieving an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline. These data showed Eucrisa to be an effective treatment that achieved statistically significant results versus vehicle for the primary efficacy endpoint in adults and children two years of age and older [32.8% versus 25.4% (P=0.038) for Trial 1 and 31.4% versus 18.0% (P<0.001) for Trial 2].1,3 Efficacy results were seen in some patients as early as day eight (first post-baseline assessment), with 13.4% of Eucrisa patients achieving success in ISGA versus 4.5% with vehicle in Trial 1 and 15.9% EUCRISA versus 6.3% vehicle in Trial 2.1,5,6
In these studies, the adverse reaction reported by more than 1% of Eucrisa patients was pain at the application site, such as stinging or burning [4% (N=45)] versus vehicle [1% (N=6)]. The rate of study discontinuation due to adverse reactions was the same in the Eucrisa group versus vehicle (1.2%).3
“After many years without new therapies, this is an exciting day for those living with mild to moderate eczema and their caregivers,” said Julie Block, president and chief executive officer of the National Eczema Association.
1 Eucrisa (crisaborole) Prescribing Information. New York. NY: Pfizer Inc: 2016.
2 Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis. 2007;18(2):82-91.
3 Paller AS, Tom WL, Lebwohl MG, et al. Efficacy and safety of crisaborole ointment, a novel, nonsteroidal phosphodiesterase 4 (PDE4) inhibitor for the topical treatment of atopic dermatitis (AD) in children and adults. J Am Acad Dermatol. 2016;75(3):494-503.
4 Sawai T, Ikai K, Uehara M. Cyclic adenosine monophosphate phosphodiesterase activity in peripheral blood mononuclear leucocytes from patients with atopic dermatitis: correlation with respiratory atopy. Br J Dermatol. 1998;138(5):846-8.
5 Data on file. Final clinical study report for AN2728-AD-301.
6 Data on file. Final clinical study report for AN2728-AD-302.
Filed Under: Drug Discovery