The Medicines and Healthcare products Regulatory Agency (MHRA)
has approved deuruxolitinib (Leqselvi) to treat
severe alopecia areata in adults.
Alopecia areata is a disease where the body's own immune system
attacks hair follicles, causing inflammation that leads to hair
loss on the scalp, face and/or other parts of the body.
Deuruxolitinib works by reducing the activity of enzymes
called JAK1, JAK2 and TYK2 relative to JAK3 kinases, which are
involved in inflammation at the hair follicle. This reduces the
inflammation, leading to hair regrowth in patients with alopecia
areata.
Beach, MHRA Executive Director,
Healthcare Quality and Access, said:
This approval gives adults with alopecia
areata another potential treatment option to
help manage their condition.
As with any medicine, the MHRA will keep the safety and
effectiveness of deuruxolitinib under close review.
Deuruxolitinib can only be obtained with a prescription. The
recommended dose is an 8 mg tablet to be
taken twice a day.
This medicine was evaluated in two pivotal clinical trials. The
trials studied 1223 adult patients with alopecia areata
that had lost at least 50% of their hair for more than 6 months.
In both trials, subjects received twice
daily either Leqselvi 8
mg, deuruxolitinib 12 mg or a placebo for 24
weeks.
After 24 weeks, the patients that
received Leqselvi scored higher on a scale used to
measure scalp hair than those that
received the placebo.
Leqselvi was shown to improve hair growth in subjects with
severe alopecia areata, with around 30% of subjects
experiencing 80% or more scalp hair after 24 weeks of treatment,
and around 23% of subjects experiencing 90% or more scalp hair
after 24 weeks of treatment.
The most common side effects with deuruxolitinib (which
may affect more than 1 in 10 people) are headache and
acne. Anyone who suspects they are having a side effect from
this medicine is encouraged to talk to their doctor,
pharmacist or nurse and report it to the Yellow Card scheme,
either through the website (https://yellowcard.mhra.gov.uk/)
or by searching the Google Play or Apple App stores for MHRA
Yellow Card.
Notes to editors
-
Deuruxolitinib was
approved on 11 March 2026 to Sun
Pharma UK Limited.
-
This medicine was approved via the International
Recognition Procedure (IRP).
-
This medicine is subject to additional monitoring
to allow quick identification of new safety
information. More information can be found in the
Summary of Product Characteristics and Patient Information
leaflets which will be published on the MHRA Products
website within 7 days of approval.
