Positive results continue to be presented for Pfizer’s Eucrisa (crisborole ointment 2%) for the treatment of patients with atopic dermatitis (AD) at the 75th Annual American Academy of Dermatology (AAD) meeting. Eucrisa is a non-steroidal topical phosphodiesterase-4 (PDE4) inhibitor that received FDA approval in December 2016 for the treatment of mild-to-moderate AD in patients ages two years and older. Eucrisa is a first-in-class PDE4 inhibitor to enter the AD treatment paradigm, as well as the first new prescription therapy to be approved for this disease space in over a decade, giving the drug a major competitive advantage in this market.
A post-hoc analysis from two identical Phase III, multicenter, vehicle controlled trials demonstrated treatment with Eucrisa provides early relief of pruritus, regardless of baseline disease severity. Patients with mild-to-moderate AD were randomly assigned 2:1 to receive Eucrisa or vehicle twice-daily for 28 days. Regardless of baseline disease severity, significantly more patients receiving Eucrisa than vehicle achieved early improvement in pruritus (mild AD: 59.5% compared with 41.3%; p<0.001; moderate AD: 54.7% compared with 38.3%; p< 0.001). At 48 hours, significantly more Eucrisa-treated patients with mild AD achieved improvement in pruritus compared with vehicle (p=0.02). In addition, mean percentage change from baseline in pruritus severity at Day 6 was significantly greater in both mild and moderate patients treated with Eucrisa compared with vehicle (mild AD: –42.9% compared with -29.2%; p=0.009; moderate AD: –40.9% compared with –26.1%; p<0.001).
Focusing on the competition, there are six other PDE4 inhibitor molecules in clinical development for AD. Although Eucrisa’s competitors are vying for entry into the mild-to-moderate AD space, Eucrisa leads the race to market, as all other contestants have yet to initiate Phase III trials. Eucrisa now marks the only branded treatment on the market, as the last remaining branded drug, Valeant’s Elidel (pimecrolimus), lost its patent protection in the US in 2016. With the backing of Pfizer and potential entry into the rest of the 7MM, Eucrisa could gain access to a total of approximately eight million drug-treated mild-to-moderate patients in the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, and Japan) by 2024.