dm+d

Unassigned

New Medicines

Moderate-to-severe alopecia areata

Information

New molecular entity
Pfizer
Pfizer

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Pre-registration (Filed)
Sep 22Pfizer announce FDA and EMA have accepted filings for ritlecitinib for adults and adolescents ≥12 years with alopecia areata. A decision from the FDA is expected Q2 23, and from the EMA Q4 23. A UK submission has also been completed, with a decision expected in 2023 [11].
Aug 21Pfizer plans to combine the phase 2b/3 ALLEGRO data with results from an ongoing long-term study to file for approval of ritlecitinib. The Big Pharma company has identified ritlecitinib as one of nine potential blockbusters it aims to launch by 2025 [9].
Sep 18The US FDA granted Breakthrough Therapy designation to PF 06651600 for the treatment of pts with alopecia areata. The designation was based on the positive results from the phase II trial.[2]

Category

Janus kinase-3 (JAK3) inhibitor
In the UK, alopecia areata is estimated to affect about 15 in 10,000 people. [1]
Moderate-to-severe alopecia areata
Oral

Further information

Yes

Trial or other data

Dec 21Recruitment to PIII ALLEGRO-LT study completes. Collection of primary outcome data is now expected to occur Apr 24 [10].
Aug 21Pfizer announce PIIb/III ALLEGRO trial met primary endpoint of improved scalp hair regrowth over a six-month observation period, with patients experiencing ≤20% scalp hair loss compared to those who took a placebo [8].
Jan 21Primary completion date for PIIb/III ALLEGRO-2b/3 is now January 2021 [7].
Nov 19The estimated primary completion date for the PIIb/III ALLEGRO-2b/3 trial (NCT03732807) is September 2020 [6].
Jul 19PIII open-label ALLEGRO-LT trial (NCT04006457) starts; it aims to evaluate the long-term safety and effectiveness of PF-06651600 in adults and adolescents (12 years and older) with alopecia areata. The estimated completion date is May 2023 [5,6].
Jan 19PIIb/III trial starts - double-blind, placebo-controlled, dose-ranging study to evaluate the safety and effectiveness of PF-06651600 in approx. 660 adults and adolescents (12 years and older) who have 50% or greater scalp hair loss (NCT03732807) [4].
Sep 18Results from the PIIa trial showed that both JAK inhibitors (PF-06651600 and PF-06700841) met the primary efficacy endpoint—improving hair regrowth on the scalp as measured by the Severity of Alopecia Tool (SALT) score. Out of the 100-point SALT score, the JAK 3 inhibitor (PF-06651600) received a score of 33.6 and the TYK2/JAK1 inhibitor had a SALT score of 49.5. Because of the results, the JAK3 inhibitor, which was granted Breakthrough Therapy designation from the FDA for alopecia areata, will advance to PIII for moderate to severe alopecia areata.[3]
Dec 16Randomised, double-blind, parallel, placebo-controlled trial PIIa trial initiated to evaluate the efficacy and safety of PF-06651600 and PF 06700841 in pts with moderate to severe alopecia areata (NCT02974868). The is enrolling approximately 132 pts in the US.[2]

Evidence based evaluations