First Medicine Recommended For Approval For Hidradenitis Suppurativa
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Treatment of this serious skin condition to be added to Humira’s approved uses
The European Medicines Agency (EMA) has recommended extending the use
of Humira (adalimumab) to include treatment of adults with active
moderate to severe hidradenitis suppurativa (acne inversa), who have
failed to respond to conventional systemic treatments. Hidradenitis
supportiva is a chronic skin disease that causes abscesses and scarring
on the skin – usually around the groin, buttocks, breasts and armpits.
Humira is the first medicine that is recommended for approval for the
treatment of this disease in the European Union (EU).
Humira was first authorised in the EU in September 2003 for the
treatment of active rheumatoid arthritis. The use of Humira was later
extended to include the treatment of other inflammatory autoimmune
conditions in adults and children, including juvenile idiopathic
arthritis, psoriatic arthritis, ankylosing spondylitis, plaque
psoriasis, Crohn's disease and ulcerative colitis.
The active substance in Humira, adalimumab, is a monoclonal antibody.
It has been designed to attach to tumour necrosis factor-alpha (TNF),
which is involved in causing inflammation and is found at high levels in
patients with the types of autoimmune diseases that Humira is used to
treat. By blocking TNF-alpha, adalimumab reduces the inflammation and
other symptoms of the diseases.
Hidradenitis suppurativa is estimated to affect about 1% of the
population in any one year, and is 2 to 5 times more common in women
than men. It ranges from mild to severe forms, but it can be progressive
in some people. It is characterised by recurrent inflamed nodules and
abscesses, which may form fistulas, leak pus and cause scarring.
Hidradenitis suppurativa can have a considerable impact on patients’
daily lives, their work/school attendance, physical activities, and
emotional state.
Currently, there are no approved medicines for the treatment of
hidradenitis suppurativa in the EU, but there are treatment
recommendations from learned societies including antibiotics to treat
infections. Surgery and/or laser treatments are sometimes used in severe
cases. The EMA’s Committee for Medicinal Products for Human Use (CHMP)
considered that there is an unmet medical need for treatment of this
condition when conventional treatments have failed.
The recommendation from the CHMP is based on the results of two main
studies in 633 people with moderate to severe hidradenitis suppurativa.
Patients in these studies were randomly assigned to receive either
Humira or placebo in addition to daily use of a topical antiseptic. Both
studies showed that patients given Humira had greater reductions in the
numbers of abscesses and inflammatory nodules than patients given
placebo.
The adverse events reported during the clinical trials of Humira for
hidradenitis suppurativa were generally similar to those seen with
Humira used in its other indications. There are some known risks with
Humira including risks of infection and malignancy. A follow-up plan to
monitor the long-term safety of Humira was agreed by the CHMP.
The company received scientific advice from the CHMP on clinical
aspects of the application. This is one of the Agency’s main tools to
facilitate and stimulate research and development within the EU.
The opinion adopted by the CHMP at its June 2015 meeting is an
intermediary step on Humira’s access to adult patients with active
moderate to severe hidradenitis suppurativa. The CHMP opinion will now
be sent to the European Commission for the adoption of a decision to
change the marketing authorisation. Once the extension of indication has
been granted, each Member State will take a decision on price and
reimbursement based on the potential role/use of this medicine in the
context of its national health system.
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