AbbVie has received approval from the European Commission (EC) for RINVOQ (upadacitinib; 15 mg and 30 mg, once daily) to treat adults and adolescents aged 12 years and older with severe alopecia areata (AA).
Alopecia areata is an autoimmune disorder that causes unpredictable hair loss, ranging from small bald patches on the scalp to complete loss of all body hair, including scalp, face, eyebrows and eyelashes. Although driven by the immune system, the disease is often mistaken as a cosmetic problem, despite its significant physical, emotional, social and economic impact.
Research indicates that alopecia areata patients have up to a 40% higher risk of developing depression and anxiety than the general population, with women facing an even greater risk.
“The European Commission’s approval of RINVOQ provides a new treatment option for the severe alopecia areata community in the EU with demonstrated scalp regrowth, including complete scalp hair regrowth for some, that can support management of the disease,” said Roopal Thakkar, executive vice president, research and development, chief scientific officer, AbbVie.
“This approval provides another option for patients who continue to navigate physical and mental burden associated with severe alopecia areata, often overlooked due to stigma,” Thakkar added.
The approval is based on data from AbbVie’s ongoing Phase 3 UP-AA clinical programme, which showed that both 15 mg and 30 mg doses of RINVOQ achieved statistically significant scalp hair regrowth and improvements in eyebrows and eyelashes at week 24.
In addition to severe alopecia areata, RINVOQ is approved in the EU for several immune-mediated conditions, including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis, radiographic axial spondylarthritis, ulcerative colitis, Crohn’s disease, giant cell arteritis and non-segmental vitiligo.
The therapy is currently being evaluated in Phase 3 clinical trials for hidradenitis suppurativa, Takayasu arteritis and systemic lupus erythematosus. Upadacitinib is also under regulatory review by the US Food and Drug Administration (FDA) for the treatment of alopecia areata.
