The European Commission has authorised the marketing of ritlecitinib to treat adults and adolescents 12 and older with severe alopecia areata, the first medicine it has approved to treat patients as young as 12.
Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3, reports MDedge.
Pfizer, which developed the drug, said approval was granted based on the pivotal ALLEGRO clinical trial programme, which included the ALLEGRO phase 2b/3 study that evaluated ritlecitinib in patients 12 and older with alopecia areata with 50% or more scalp hair loss, including those with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss).
Results showed that 13.4% of adults and adolescents achieved 90% or more scalp hair coverage (Severity of Alopecia Tool score of 10 or less) after 24 weeks of treatment with ritlecitinib 50mg, compared with 1.5% of those on placebo.
The study also measured Patient Global Impression of Change (PGI-C). At week 24, 49.2% of participants treated with ritlecitinib reported a PGI-C response of “moderate” to “great” improvement in their alopecia areata, compared with 9.2% with placebo.
In an ongoing, long-term phase 3 study of ALLEGRO-LT, the most common adverse reactions included diarrhoea (9.2%), acne (6.2%), upper respiratory tract infections (6.2%), urticaria (4.6%), rash (3.8%), folliculitis (3.1%), and dizziness (2.3%).
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