View the Comparison Table: Some Lipid-Lowering Drugs

Mild to moderate plaque psoriasis can be treated with topical drugs and phototherapy. Patients with moderate to severe disease generally require systemic therapy. Guidelines for the treatment of psoriasis with topical therapy, phototherapy, and systemic drugs have recently been published.

The FDA has approved the complement C5 inhibitor zilucoplan (Zilbrysq – UCB) for once-daily subcutaneous treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. Zilucoplan is the first complement inhibitor to be approved for treatment of myasthenia gravis that can be self-administered. Two IV complement inhibitors, eculizumab (Soliris) and ravulizumab (Ultomiris), were approved earlier.

The FDA has approved Combogesic IV (Hikma), an IV solution containing acetaminophen and ibuprofen, to treat mild to moderate pain (alone) or moderate to severe pain (in combination with an opioid) in adults when IV analgesia is considered clinically necessary. Single-drug IV solutions containing ibuprofen (Caldolor) and acetaminophen have been available in the US for years.

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.

The FDA has approved clesrovimab-cfor (Enflonsia – Merck), a long-acting monoclonal antibody, for prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants born during or entering their first RSV season. Clesrovimab is the second drug to be approved for this indication; nirsevimab (Beyfortus), another long-acting monoclonal antibody, was the first. Palivizumab (Synagis), a shorter-acting antibody, is FDA-approved for prevention of severe RSV LRTI in certain high-risk children ≤24 months old.

Relyvrio, the fixed-dose combination of sodium phenyl-butyrate and taurursodiol that received accelerated approval for treatment of amyotrophic lateral sclerosis (ALS) in 2022 based on a phase 2 trial showing that it slowed functional decline, has voluntarily been withdrawn from the market. According to the manufacturer (Amylyx), the decision to withdraw Relyvrio was based on the results of a phase 3, 48-week trial (PHOENIX). The change from baseline on the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale, which measures fine motor, gross motor, bulbar, and respiratory...

The FDA has announced that prescribers, pharmacies, and patients are no longer required to participate in a Risk Evaluation and Mitigation Strategy (REMS) program for the second-generation antipsychotic drug clozapine (Clozaril, and others).

Xywav (Jazz), an oral solution that contains calcium, magnesium, potassium, and sodium oxybates, has been approved by the FDA for treatment of idiopathic hypersomnia in adults. It is the first drug to be approved in the US for this indication. Xywav was approved in 2020 for treatment of excessive daytime sleepiness or cataplexy in patients ≥7 years old with narcolepsy. It contains about 92% less sodium than sodium oxybate oral solution (Xyrem), which has been available in the US for years for use in patients ≥7 years old with narcolepsy.

The FDA has approved Acuvue Theravision with Ketotifen (Johnson & Johnson Vision Care), a daily-wear, disposable, vision-correcting soft contact lens that releases the H₁-antihistamine ketotifen, for prevention of ocular itch due to allergic conjunctivitis in contact lens users. This is the first approval for a drug-eluting contact lens. Ketotifen eye drops (Alaway, Zaditor, and others) are available over the counter.