The FDA has approved the injectable interleukin (IL)-17A/17F antagonist bimekizumab-bkzx (Bimzelx – UCB) for treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic treatment or phototherapy. Bimekizumab is the first IL-17A/17F antagonist to be approved in the US. It was approved in the European Union for the same indication in 2021.

The FDA has approved use of lubiprostone (Amitiza) for treatment of opioid-induced constipation in adults with chronic non-cancer pain. The drug was previously approved for chronic idiopathic constipation and irritable bowel syndrome with constipation.

The oral retinoid isotretinoin (Accutane, and others) is the most effective drug available for treatment of acne.1 The FDA has recently approved a new oral isotretinoin product (Absorica – Cipher/Ranbaxy) for treatment of severe, recalcitrant nodular acne.Isotretinoin can completely clear severe nodulocystic lesions, in some cases leading to remission that can persist for years after treatment is stopped. Mucocutaneous adverse effects include dry skin, dry eye, epistaxis, nasopharyngitis, cheilitis, alopecia, eczema, skin fragility and photosensitivity. Musculoskeletal symptoms,...

The FDA has approved lubiprostone (Amitiza - Sucampo/Takeda), a chloride channel activator, for treatment of chronic idiopathic constipation in adults. The only other prescription drug approved by the FDA for this indication (in 2004 for adults <= 65 years old) is tegaserod (Zelnorm), a partial agonist of serotonin that is also approved for constipation-predominant irritable bowel syndrome in women. Of course, numerous over-the-counter products are available for treatment of constipation.

The FDA has approved golimumab (Simponi – Janssen), a fully human monoclonal antibody specific for tumor necrosis factor (TNF) alpha, for induction and maintenance of remission in patients with moderate to severe ulcerative colitis who do not respond to or cannot tolerate other therapies or who require continuous treatment with corticosteroids. Golimumab was approved earlier for treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is the third TNF inhibitor to be approved for use in ulcerative colitis.

The FDA has approved a 0.016% gel formulation of the nitrogen mustard mechlorethamine (Valchlor – Actelion) for second-line topical treatment of patients with stage IA or IB mycosis fungoides, the most common type of cutaneous T-cell lymphoma. Topical nitrogen mustard has been used off-label for decades for this indication, usually as a pharmacy-compounded ointment, but no clinical trials evaluating its efficacy and safety have been done. Mechlorethamine is also available in an injectable formulation (Mustargen – Recordati) for the same and other indications.FDA approval of Valchlor was...

The FDA has approved the Obalon Balloon System (Obalon), a swallowable intragastric gas-filled balloon device, to facilitate weight loss in adults with a body mass index (BMI) of 30-40 kg/m² who have not been able to lose weight through diet and exercise. Two other gastric balloon devices, ReShape and Orbera, were approved earlier.

The FDA has approved the interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) for treatment of moderately to severely active ulcerative colitis (UC) in adults. Mirikizumab is the first selective IL-23 antagonist to be approved for this indication. Ustekinumab (Stelara), an IL-12/23 antagonist, was approved for treatment of UC in 2019. The IL-23 antagonist risankizumab (Skyrizi) is approved for treatment of Crohn's disease.

Certolizumab pegol (Cimzia – UCB), a tumor necrosis factor (TNF) inhibitor previously approved for treatment of Crohn's disease and rheumatoid arthritis, and ustekinumab (Stelara – Janssen), a human interleukin-12 and -23 antagonist previously approved for treatment of moderate-to-severe plaque psoriasis, have now been approved by the FDA for treatment of active psoriatic arthritis.

The interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active ulcerative colitis (UC) in adults; it was approved earlier for treatment of plaque psoriasis and psoriatic arthritis. Guselkumab is the third IL-23 antagonist to be approved in the US for treatment of UC; risankizumab (Skyrizi) and mirikizumab (Omvoh) were approved earlier.