FDA Expands Cosentyx Label to Adolescents who have Hidradenitis Suppurativa
On March 13, 2026, the US Food and Drug Administration (FDA) approved Novartis’ Cosentyx® (secukinumab) injection for the treatment of moderate to severe hidradenitis suppurativa (HS) in pediatric patients aged 12 years and older. Previously, it was only approved for adults who had this chronic inflammatory skin disease. HS is a chronic inflammatory disease characterized by recurrent lesions that commonly begin around puberty, making adolescence an important period for diagnosis and disease management. Approval is supported by well‑controlled adult studies and pharmacokinetic modeling extrapolated from adult hidradenitis suppurativa and psoriasis trials, along with pediatric clinical data from other approved indications, showing that weight‑based dosing in patients aged 12 years and older and weighing at least 30kg achieves drug exposure comparable to that seen in adults with HS. The recommended dosing for treating HS in pediatric patients weighing 30kg to less than 90kg is 150mg by subcutaneous (SC) injection at weeks zero, one, two, three, and four and every four weeks thereafter. For patients weighing at least 90kg, the recommended dose is 300mg at that same schedule. Cosentyx is an interleukin‑17A (IL‑17A) inhibitor, and this marks its fourth pediatric indication. Here is the full prescribing information.
Wegovy HD (7.2mg) Approved
The FDA approved Novo Nordisk’s Wegovy® HD (semaglutide) 7.2mg once‑weekly SC injection for chronic weight management in adults who have obesity and have tolerated the 2.4mg dose for at least four weeks and require additional weight reduction on March 19, 2026. Prior to this approval, the highest dose available for weight loss was 2.4mg. Approval was based on the STEP-UP phase III program, in which adults with obesity achieved a mean weight loss of 21% at 72 weeks, compared to 18% with the 2.4mg dose and 2% with placebo. About 33% of patients on the higher dose lost at least 25% of their body weight, compared with 17% on the standard dose and none on placebo. Gastrointestinal side effects and dysesthesia (altered skin sensations) occurred more frequently with the 7.2mg dose than with the 2.4mg dose or placebo. Wegovy HD, administered via a single-dose pen, is used alongside a reduced‑calorie diet and increased physical activity. This was reviewed under the FDA’s Commissioner’s National Priority voucher (CNPV) pilot, which accelerates review for products addressing major national health priorities. It is the fourth approval under the program and was granted in 54 days after filing. Wegovy HD is expected to launch in the US in April 2026. Full prescribing information is available here.
Generic Savella Launched
On March 19, 2026, Breckenridge Pharmaceutical announced the launch of milnacipran tablets, the generic equivalent of Savella® by AbbVie. A selective serotonin and norepinephrine dual reuptake inhibitor approved for the management of fibromyalgia, it will be available in 12.5mg, 25mg, 50mg, and 100mg strengths. Breckenridge’s product is the first to announce launch; however, multiple manufacturers are expected to launch in March 2026. Savella had estimated annual sales of $113 million in 2025.
Imcivree Gets New Indication as First Treatment for Acquired Hypothalamic Obesity
The FDA, on March 19, 2026, approved Rhythm Pharmaceuticals’ Imcivree® (setmelanotide) for the treatment of acquired hypothalamic obesity (HO) in adults and pediatric patients aged four years and older, making it the first FDA‑approved therapy for this rare condition. Acquired hypothalamic obesity is characterized by accelerated and sustained weight gain caused by hypothalamic injury or dysfunction, most commonly following tumors or their treatment. Rhythm estimates that about 10,000 Americans live with HO. Imcivree is a melanocortin‑4 receptor (MC4R) agonist designed to address the underlying biology of HO by regulating hunger and energy balance. Approval was based on a 18.4% placebo‑adjusted reduction in body mass index (BMI) at 52 weeks, demonstrating statistically and clinically meaningful weight loss. It is administered as a once-daily SC injection, starting at 0.5mg daily for two weeks and increasing to a 3mg once‑daily maintenance dose, with weight‑based dosing used in children four to six years of age. Imcivree’s initial FDA approval came in November 2020 for the treatment of obesity caused by ultra‑rare genetic deficiencies of pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) deficiency, with a subsequent approval for Bardet‑Biedl syndrome. Updated prescribing information can be found here.
Recall
Medical Device Correction for Omnipod 5 Pods
On March 12, 2026, Insulet Corporation initiated a voluntary medical device correction of certain Omnipod® 5 Pods. The action was prompted by a manufacturing issue in which some Pods from specific lots may have a small tear in the internal insulin‑delivery tubing, potentially resulting in under‑delivery of insulin. In medically significant cases, this may lead to hyperglycemia and diabetic ketoacidosis (DKA). Insulet reported 18 serious adverse events, including hospitalizations and DKA, and no deaths have been reported. Omnipod 5 is an automated insulin delivery system used for continuous subcutaneous insulin infusion in individuals with diabetes. The medical device correction is limited to specific lots distributed in the US. For more information, see here.