The FDA has approved Bimzelx for adults with hidradenitis suppurativa (HS) or acne inversa, a type of chronic skin inflammation that affects about 1 in 100 people. The approval marks the fifth indication for the drug and provides a first-of-its-kind treatment for this condition.
HS usually happens when hair follicles become blocked and inflamed, causing painful lumps under the skin, usually in areas like the armpits, groin, buttocks, and under the breasts. These bumps can swell, get infected, break open, leak fluid or pus, and even leave scars. Frequent painful flare-ups can interfere with a person’s daily activities and may even negatively impact their overall well-being.
Bimzelx, the brand name for the drug bimekizumab, is a monoclonal antibody, a type of medicine that uses your body’s immune system to fight disease, and is the first and only approved treatment that blocks both interleukin 17F and interleukin 17A, key proteins that cause inflammation in HS. This dual action helps control inflammation more effectively and reduces the severity of symptoms. First approved in 2023, Bimzelx also treats conditions like psoriasis, psoriatic arthritis, and certain types of spine and joint inflammation.
Bimzelx was tested in two studies with 1,014 patients with moderate to severe HS. By week 16, more patients on Bimzelx saw at least 50% improvement compared to those on a placebo, with symptom relief lasting up to 48 weeks. The manufacturer, UCB, reported no new safety concerns, consistent with earlier trials.
Bimzelx will be available as a single-dose prefilled syringe or single-dose prefilled autoinjector that patients or their caregivers can learn to use with some training.
Side effects include upper airway infections, reactions at the injection site, fungal skin infections (tinea), rash, cold sores, acne, hair follicle infections, oral thrush and other yeast infections, stomach flu, headaches, and tiredness. As per UCB’s press release, patients should discuss their medical history with their doctor before taking Bimzelx, especially if they have scheduled vaccinations, infections, liver problems, or other conditions like tuberculosis and inflammatory bowel disease. The drug may increase the risk for suicidal thoughts or behavior, so patients with a history of depression or mood disorders should be closely monitored.
