Brussles, Belgium — UCB said Friday it received a positive Committee for Medicinal Products for Human Use (CHMP) opinion for BIMZELX for treating moderate to severe hidradenitis suppurativa (HS), a chronic, inflammatory skin condition.
The opinion is based on Phase 3 data showing significant improvements with bimekizumab, targeting IL-17F and IL-17A, UCB said. If approved by the European Commission, it would be the fourth indication for bimekizumab in three years.
Severe Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin condition characterized by the presence of painful, deep-seated nodules and abscesses, primarily in areas where skin rubs together, such as the armpits, groin, buttocks, and under the breasts. In its severe form, HS can lead to extensive, interconnected tunnels known as sinus tracts or fistulas under the skin, and large, scarring lumps. These lesions can cause significant pain, discomfort, and drainage of pus, severely impacting the patient’s quality of life.
The exact cause of HS is not fully understood, but it involves a combination of genetic, environmental, and immune system factors. Treatment often includes antibiotics, hormonal therapy, and immunosuppressants, and in some cases, surgery may be necessary to remove the affected skin areas. Severe HS can also have a profound psychological impact, leading to depression and social isolation due to its symptoms and the stigma associated with the condition.
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