FDA Expands Bimzelx Approval to Three Additional Autoimmune Indications

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The FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis, according to the details of a news release published today. It works by inhibiting the two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F). Bimzelx was initially approved last year for the treatment of adults with moderate to severe plaque psoriasis.

Psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis are autoimmune diseases characterized by chronic inflammation. Psoriatic arthritis affects about 30% of people living with psoriasis, and symptoms include joint pain and stiffness, skin plaques and swollen toes and fingers.

Non-radiographic axial spondyloarthritis and ankylosing spondylitis cause inflammation in the lower spine and sacroiliac (SI) joints, which are the joints that connect the lower spine and pelvis. The most common symptom of ankylosing spondylitis is lower back pain that improves with exercise but not with rest. Ankylosing spondylitis usually begins before the age of 45 and about 10% to 40% of patients progress to non-radiographic axial spondyloarthritis over the next two to 10 years. The term 'non-radiographic' refers to the lack of radiographic evidence of joint damage.

The recommended dosage of Bimzelx is a 160 mg subcutaneous injection given every four weeks.

Data for approval of Bimzelx for psoriatic arthritis was gathered during the phase 3 BE OPTIMAL and BE COMPLETE studies where success was measured using the American College of Rheumatology 50 score, which means there was a 50% improvement in disease response. Forty-four percent of patients in BE OPTIMAL and 43% of patients in BE COMPLETE achieved an ACR50 response by week 16 with symptoms controlled up to 52 weeks, when compared to placebo.

Bimzelx treatment success for non-radiographic axial spondyloarthritis and ankylosing spondylitis was measured during the BE MOBILE 1 and BE MOBILE 2 studies. Almost half of participants (47.7% and 44.8%) in both studies had at least a 40% improvement in symptoms by week 16, when compared with placebo.

The most common side effects were upper respiratory tract infections, oral candidiasis and headaches, reported in at least 2% of patients.

Bimzelx is currently available for prescription. The list price is $7,552.80 per 1 mL auto injector or syringe. Pricing depends on insurance coverage and some patients with commercial insurance may pay as little as $5 per dose. The drugmaker UCB will provide Bimzelx for $15 a dose for two years if insurance coverage is delayed or denied. This program is exclusively for the benefit of the patient and will be credited in full toward patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles.