dm+d

Unassigned

New Medicines

CibinqoAtopic dermatitis

Information

Cibinqo
New molecular entity
Pfizer
Pfizer

Development and Regulatory status

Approved (Licensed)
Pre-registration (Filed)
Pre-registration (Filed)
Sep 21Approved in UK for treatment of moderate to severe atopic dermatitis in adults and adolescents aged ≥12 years, who are candidates for systemic therapy [21].
Jul 21Pfizer announce that FDA will not meet PDUFA goal due to its ongoing review of Pfizer´s post-marketing study, ORAL Surveillance, evaluating tofacitinib in RA patients. An updated PUDFA goal date has not been announced [19].
Apr 21Pfizer announce the FDA has extended the priority review period for the New Drug Application (NDA) for abrocitinib for the treatment of adults and adolescents with moderate to severe atopic dermatitis. The Prescription Drug User Fee Act (PDUFA) goal date has been extended three months to early Q3 2021 [17].
Feb 21Granted Early Access to Medicines Scheme (EAMS) status in UK for treatment of adult and adolescent patients with severe atopic dermatitis who have not responded to approved treatments or who are ineligible or intolerant to approved treatments [15].
Nov 20FDA decision is expected by April 2021 [11].
Oct 20FDA grants Priority Review and EMA accepts regulatory submission for abrocitinib as treatment of moderate to severe atopic dermatitis [13].
Feb 18The FDA has granted Breakthrough Therapy designation to abrocitinib for the treatment of moderate to severe atopic dermatitis [3].

Category

Oral JAK-1 inhibitor
Atopic eczema is common and the prevalence is increasing. It is seen in 20% of children in developed countries and in developing countries the prevalence is heading towards this figure. In adults, population studies report an overall prevalence of 2-18% [2].
Atopic dermatitis
Oral

Further information

Yes

Trial or other data

Aug 21Results of PIII JADE TEEN (NCT03796676) RCT reported in JAMA [20].
Mar 21Further results from JADE TEEN are available; at week 12, 46.2% of those on abrocitinib 200mg and 41.6% of those on abrocitinib 100mg achieved IGA responses vs. 24.5% of those on placebo. Additionally, 72% of those on 200mg and 68.5% of those on 100mg had a 75% or greater improvement in EASI-75 vs. 41.5% of those on placebo [18].
Mar 21Results of PIII JADE COMPARE trial (NCT03720470) reported in NEJM [16].
Nov 20Pfizer announce data from fifth PIII trial of abrocitinib at a dose of 200mg once a day for 12 weeks. Patients who responded were then randomised to placebo, or 200mg or 100mg of abrocitinib for 40 weeks. The probability of not experiencing a flare was 81.8% in the 200mg cohort, 57.4% in the 100mg arm and 19.1% in the placebo arm [11].
Jul 20 The PIII JADE-MONO1 study (n=387) is published; more patients randomised to abrocitinib achieved an Investigator Global Assessment response (24% for 100mg [p=0.0037] and 44% for 200mg [p<0.0001] vs 8% placebo) and an EASI-75 response (40% for 100mg [p<0.0001] and 63% for 200mg [p<0.0001] vs 12% placebo) [12].
Jun 20Positive top-line data from the Jade TEEN study announced. The company said that both doses of abrocitinib met the co-primary endpoints and were generally well tolerated with safety consistent with previous studies. Full data were not made available. [11]
May 20PIII JADE MONO-2 (n=391) is published; it reported that abrocitinib was well tolerated and significantly improved signs and symptoms of atopic dermatitis based on IGA response and EASI-75 compared with placebo in adolescent and adult patients at week 12. Among patients with available data at week 12, greater proportions of patients in the 200- and 100-mg abrocitinib groups vs placebo achieved IGA (59 of 155 [38.1%] and 44 of 155 [28.4%] vs 7 of 77 [9.1%]; P < .001) and EASI-75 (94 of 154 [61.0%] and 69 of 155 [44.5%] vs 8 of 77 [10.4%]; P < .001), greater estimated proportions achieved PP-NRS (55.3% [95% CI, 47.2%-63.5%] and 45.2% [95% CI, 37.1%-53.3%] vs 11.5% [95% CI, 4.1%-19.0%]; P < .001), and/or greater proportions achieved EASI-90 (58 of 154 [37.7%] and 37 of 155 [23.9%] vs 3 of 77 [3.9%]) responses [10].
Apr 20PIII JADE TEEN trial has completed; the randomized, double blind, placebo controlled, parallel group study evaluated the efficacy and safety of abrocitinib in adolescent participants 12 to <18 years of age with moderate to severe AD. Results are awaited [9].
Mar 20Positive top-line results from PIII JADE COMPARE trial which met its co-primary efficacy endpoints. The PIII study evaluated the safety and efficacy of abrocitinib 200mg + background topical therapy vs. s.c. dupilumab and placebo. The percentage of pts achieving each co-primary efficacy endpoint at Wk 12 was superior vs. placebo. Dupilumab demonstrated superiority vs. placebo at Week 12 and Week 16. A larger percentage of pts receiving abrocitinib 200mg experienced adverse events (61.9%) than in other treatment arms. [8]

Oct 19: Data from completed PIII JADE MONO-1 trial in pts aged >12 with moderate to severe AD presented who received abrocitinib 200mg (n=154), 100mg (n=156) or placebo (n=77). Co-primary endpoints were met; the proportion of pts acheiving an Investigator Global Assessment (IGA) score of clear (0) or almost clear (1) skin was 43.8%, 23.7% and 7.9% fpr 200mg or 100mg abcrocitibib and placebo respectively. The proportion with >2-point improvement vs. baseline and >75% change from baseline in Eczema Area and Severity Index (EASI) scores were 62.7%, 39.7% and 11.8% respectively. A key secondary endpoint was the proportion of pts achieving >4-point reduction in itch severity on the pruritus numerical rating scale (NRS) - this was acheived by 57.2%, 37.7% and 15.2% respectively. Abrocitinib was well tolerated and safety data were consistent with JADE MONO-2 trial. The most frequently reported adverse events in abrocitinib-treated pts were short-lasting nausea (20.1%, 9.0%), headache (9.7%, 7.7%), and nasopharyngitis (11.7%, 14.7%), while for placebo, it was dermatitis (16.9%). [7]/p>


Jun 18: PIII JADE Mono-2 trial (NCT03575871) to evaluate the safety and efficacy of abrocitinib in patients aged 12 years and older with moderate-to-severe atopic dermatitis. The study aims to enrol around 375 patients in the US [3].


Mar 18: PIII JADE EXTEND trial (NCT03422822) to evaluate the safety and efficacy abrocitinib, with or without topical medications in patients aged 12 years and older with moderate-to-severe atopic dermatitis, has started. The study is enrolling around 1,435 patients in the US [3].


Dec 17: PIII trial is a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of PF-04965842 in 375 patients 12 years and older with moderate-to-severe AD [1].

Evidence based evaluations