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Date: 2016-12-14

Type of information: Granting of a Market Authorisation in the US

Product name: Eucrisa®

Compound: crisaborole topical ointment (AN2728)

Therapeutic area: Dermatological diseases - Inflammatory diseases

Action mechanism:

phosphodiesterase 4 inhibitor. Crisaborole topical ointment, 2%, is an investigational non-steroidal topical anti-inflammatory PDE-4 inhibitor. This novel boron-containing small molecule inhibits PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis.

Company: Anacor Pharmaceuticals (US - CA), now Pfizer (USA - NY)

Disease:

mild-to-moderate atopic dermatitis in children and adults

Latest news:

* On December 14, 2016, the FDA  approved Eucrisa® (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. Eucrisa®, applied topically twice daily, is a phosphodiesterase 4 (PDE-4) inhibitor, although its specific mechanism of action in atopic dermatitis is not known. The safety and efficacy of Eucrisa® were established in two placebo-controlled trials with a total of 1,522 participants ranging in age from two years of age to 79 years of age, with mild to moderate atopic dermatitis. Overall, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment. Serious side effects of Eucrisa® include hypersensitivity reactions. Eucrisa® should not be used in patients who have had a hypersensitivity reaction to Eucrisa®’s active ingredient, crisaborole. The most common side effect of Eucrisa is application site pain, including burning or stinging.

* On March 22, 2016, Anacor Pharmaceuticals announced that the FDA has accepted for review Anacor's New Drug Application (NDA) seeking approval of crisaborole topical ointment, 2%, for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA's review is January 7, 2017 .

* On January 7, 2016, Anacor Pharmaceuticals announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.
In July 2015 , Anacor announced the positive top-line results from its two Phase 3 pivotal studies of crisaborole. In each of the two Phase 3 pivotal studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies. In October 2015 , Anacor announced the top-line results from its long-term safety study, in which crisaborole was found to be well-tolerated and demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months.

Patents:

Submission of marketing authorization application USA : 2016-01-07

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2016-12-14

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes