5 FDA Firsts From March

To close out the first quarter of 2026, the FDA granted various approvals in March, including first-ever treatments for some disease states and first-in-class therapies for others.

In particular, patients with hypothalamic obesity (HO) and those with primary biliary cholangitis (PBC) experiencing cholestatic pruritus now have their first FDA-approved treatment options. Meanwhile, first-in-class approvals included an oral tyrosine kinase 2 (TYK2) inhibitor for active psoriatic arthritis (PsA), an oral IL-23–targeting peptide for plaque psoriasis, and once-weekly insulin icodec-abae for type 2 diabetes (T2D).

Learn more about these 5 FDA firsts below:

FDA Approves First TYK2 Inhibitor for Adults With Active Psoriatic Arthritis

At the start of the month, on March 6, the FDA approved deucravacitinib (Sotyktu; Bristol Myers Squibb), an oral selective TYK2 inhibitor, for adults with active PsA, making it the first TYK2 inhibitor approved for this indication.¹

The approval was based on positive results from the phase 3 POETYK PsA-1 (NCT04908202) and POETYK PsA-2 (NCT04908189) trials, which evaluated the efficacy and safety of deucravacitinib 6 mg once daily in adults with active PsA. Presented last summer at the EULAR 2025 Congress, the findings demonstrated deucravacitinib’s potential as a new treatment option for patients who are biologic naive or have had prior therapy, with clinical responses maintained through week 52.

Specifically, in the POETYK PsA-1 trial, those treated with deucravacitinib experienced statistically significant improvements in American College of Rheumatology 20 (ACR20), ACR50, and ACR70 responses compared with placebo. The patients also had substantial skin clearance vs placebo, as shown by Psoriasis Area and Severity Index (PASI) 75 responses (51.9% vs 7.1%) by week 16.

Deucravacitinib demonstrated sustained improvement in clinical responses through week 52 in patients with active PsA throughout the POETYK PsA-2 trial. At week 16, significantly more patients receiving deucravacitinib achieved an ACR20 response than those receiving placebo (54.2% vs 39.4%; P = .0002); ACR20 rates increased to 62.2% for patients on continuous deucravacitinib and 67.3% for those who switched from placebo by week 52. Researchers noted that improvements in ACR50, ACR70, PASI 75, HAQ-DI, MDA response, and SF-36 PCS were maintained or enhanced through week 52.

“The psoriatic disease community has been waiting for an additional oral treatment to address the debilitating joint and skin symptoms of this disease,” Steven Taylor, president and CEO of the Arthritis Foundation, said in a news release.² “We welcome this new treatment option for people living with PsA.”

FDA Approves Icotrokinra, First Oral IL-23 Inhibitor for Plaque Psoriasis

Less than 2 weeks later, on March 18, the agency approved icotrokinra (Icotyde; Johnson & Johnson) to treat adults and pediatric patients 12 years and older with moderate to severe plaque psoriasis.³ The approval made icotrokinra the first and only targeted oral peptide that blocks the IL-23 receptor to help achieve skin clearance, marking a shift in the delivery of systemic therapy among this population.

The decision was based on data from the ICONIC clinical development program, which includes 5 randomized, controlled, phase 3 trials: ICONIC-LEAD (NCT06095115), ICONIC-TOTAL (NCT06095102), ICONIC-ADVANCE 1 (NCT06143878), ICONIC-ADVANCE 2 (NCT06220604), and ICONIC-ASCEND (NCT06934226).

Icotrokinra showed superiority over both placebo and deucravacitinib in the ongoing head-to-head ICONIC-ADVANCE 1 and 2 trials. At week 16, about 70% of patients receiving icotrokinra achieved an Investigator’s Global Assessment (IGA) score of 0 or 1, indicating clear or almost clear skin. In addition, 55% achieved at least a 90% improvement in PASI (PASI 90).

The robust efficacy vs placebo was further demonstrated by the ICONIC-LEAD trial, with coprimary end points PASI 90 and IGA 0/1 experiencing at least a 2-grade improvement. Longer-term data from the trial also suggest maintenance of response through week 52, including in adolescent populations.

Lastly, in ICONIC-TOTAL, which evaluated patients with psoriasis affecting high-impact areas like the scalp, hands, feet, and genitals, icotrokinra showed meaningful skin clearance. Researchers emphasized the importance of these findings, as these regions are often associated with disproportionate quality-of-life burden.

“Finding the right treatment can take time, during which people with psoriatic disease should be considering multiple factors from efficacy to safety to how the treatment fits into their everyday life,” Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation, said in a statement.⁴ “The approval of a novel systemic therapy changes the conversation about treatment options for our community.”

FDA Approves Linerixibat for Cholestatic Pruritus in Primary Biliary Cholangitis

One day later, linerixibat (Lynavoy; GSK) became the first FDA-approved drug for patients with cholestatic pruritus, an internal itch in patients with PBC, a rare autoimmune disease that disrupts bile flow from the liver, causing symptoms such as sleep disturbance, impaired quality of life, and fatigue.⁵

Linerixibat attempts to address the circulation of excess bile acids, which is thought to cause cholestatic pruritus, by acting as an ileal bile acid transporter inhibitor to prevent bile reuptake in the body.

The approval was based on data from the phase 3 GLISTEN trial (NCT04950127). Investigators found a change in patients’ monthly itch score from baseline through week 24. Specifically, the least squares mean change in itch score, rated between 0 and 10, was –2.86 (95% CI, –3.23 to –2.50) in the linerixibat group and –2.15 (95% CI, –2.51 to –1.78) in the placebo group.

“The approval of linerixibat represents an important opportunity to improve the lives of people with PBC and who struggle with uncontrolled and often debilitating pruritus,” Christopher Bowlus, MD, chief of gastroenterology and hepatology at the University of California, Davis, said in a news release.⁶ “…The FDA’s decision marks a major milestone in PBC pruritus care that addresses a critical area of unmet need.”

FDA Approves Setmelanotide for Adult and Pediatric Patients With Acquired Hypothalamic Obesity

That same day, setmelanotide (Imcivree; Rhythm Pharmaceuticals), a melanocortin 4 receptor agonist, became the first FDA-approved therapy for acquired HO, a rare disease caused by hypothalamic injury or dysfunction that leads to accelerated and sustained weight gain, in patients 4 years and older.⁷

Approval was based on positive results from the phase 3 TRANSCEND trial of the treatment in patients with acquired HO (NCT05774756). The ongoing global study had new results read out on March 1 for 142 patients over 52 weeks, adding to the topline results announced in April 2025, which showed that TRANSCEND met its primary and key secondary end points.

Specifically, these new findings showed the study achieved its primary end point with a –18.8% placebo-adjusted difference in body mass index (BMI) reduction for the setmelanotide group. Therefore, mean BMI change from baseline was –16.4% for the treatment group (n = 94) vs 2.4% for the placebo group (n = 48) (P < .0001). Additionally, among patients aged 12 and older, the setmelanotide group had a mean weekly reduction of 2.5 points in the weekly average most hunger score vs a reduction of 1.3 points in the placebo group (P = .0015).

“Having a therapy for individuals and families affected by acquired hypothalamic obesity has the potential to be transformational,” Amy Wood, executive director and founder of the Raymond A. Wood Foundation, a nonprofit dedicated to advocacy for survivors of hypothalamic-pituitary brain tumors, said in a statement.⁸ “…[Setmelanotide] offers hope and a path forward for thousands of patients who have long been without options.”

FDA Approves Novel Weekly Basal Insulin for T2D

Before the month’s end, on March 26, the agency approved once-weekly insulin icodec-abae (Awiqli; Novo Nordisk) for adult patients with T2D, with the 700-units/mL dose projected to launch in the second half of 2026.⁹ The treatment option is first in its class, freeing this patient population from its strict schedule of daily basal insulin injections and reducing total injections from 7 to 1 for each 7-day period.

The approval was supported by 4 of the 6 phase 3a trials in the ONWARDS program, involving 2680 adult patients with uncontrolled T2D. The primary end point of interest was hemoglobin A_1c reduction.

Insulin icodec-abae is indicated as an adjunct to diet and exercise for improved glycemic control, as well as for those also taking mealtime insulin or another common oral antidiabetic agent and/or a glucagon-like peptide-1 receptor agonist. Administration of the treatment is with or without food via a prefilled FlexTouch device on the same day each week.

“Awiqli is an important new option that meets a real need as the first FDA-approved, once-weekly basal insulin for adult patients with type 2 diabetes,” Anna Windle, PhD, Novo Nordisk’s group vice president of clinical development and medical and regulatory affairs, said in a news release.¹⁰ “…Awiqli may address challenges associated with the frequency of daily basal injections by reducing them from 7 to 1 per week.”

References

1. McCormick B. FDA approves first TYK2 inhibitor for adults with active psoriatic arthritis. AJMC^®. March 9, 2026. Accessed April 3, 2026. https://www.ajmc.com/view/fda-approves-first-tyk2-inhibitor-for-adults-with-active-psoriatic-arthritis
2. US FDA approves Bristol Myers Squibb’s Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis. News release. Bristol Myers Squibb. March 6, 2026. Accessed April 3, 2026. https://news.bms.com/news/corporate-financial/2026/U-S--FDA-Approves-Bristol-Myers-Squibbs-Sotyktu-deucravacitinib-for-the-Treatment-of-Adults-with-Active-Psoriatic-Arthritis/default.aspx
3. McNulty R. FDA approves icotrokinra, first oral IL-23 inhibitor for plaque psoriasis. AJMC. March 18, 2026. Accessed April 3, 2026. https://www.ajmc.com/view/fda-approves-icotrokinra-first-oral-il-23-inhibitor-for-plaque-psoriasis
4. FDA approval of Icotyde (icotrokinra) ushers in new era for first-line systemic treatment of plaque psoriasis with a targeted oral peptide. News release. Johnson & Johnson. March 18, 2026. Accessed April 3, 2026. https://www.investor.jnj.com/investor-news/news-details/2026/FDA-approval-of-ICOTYDE-icotrokinra-ushers-in-new-era-for-first-line-systemic-treatment-of-plaque-psoriasis-with-a-targeted-oral-peptide/default.aspx
5. Bonavitacola J. FDA approves linerixibat for cholestatic pruritus in primary biliary cholangitis. AJMC. March 19, 2026. Accessed April 3, 2026. https://www.ajmc.com/view/fda-approves-linerixibat-for-cholestatic-pruritus-in-primary-biliary-cholangitis
6. Lynavoy (linerixibat) approved by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC). News release. GSK. March 19, 2026. Accessed March 19, 2026. https://www.gsk.com/en-gb/media/press-releases/lynavoy-linerixibat-approved-by-the-us-fda/
7. Mattina C. FDA approves setmelanotide for adult and pediatric patients with acquired hypothalamic obesity. AJMC. March 20, 2026. Accessed April 3, 2026. https://www.ajmc.com/view/fda-approves-setmelanotide-for-adult-and-pediatric-patients-with-acquired-hypothalamic-obesity
8. Rhythm Pharmaceuticals announces FDA approval of Imcivree (setmelanotide) for patients with acquired hypothalamic obesity. News release. Rhythm Pharmaceuticals. March 19, 2026. Accessed April 3, 2026. https://ir.rhythmtx.com/news-releases/news-release-details/rhythm-pharmaceuticals-announces-fda-approval-imcivreer-1
9. Shaw ML. FDA approves novel weekly basal insulin for T2D. AJMC. March 30, 2026. Accessed April 3, 2026. https://www.ajmc.com/view/fda-approves-novel-weekly-basal-insulin-for-t2d
10. FDA approves Novo Nordisk’s Awiqli, the first and only once-weekly basal insulin treatment for adults with type 2 diabetes. News release. Morningstar. March 26, 2026. Accessed April 3, 2026. https://www.morningstar.com/news/pr-newswire/20260326ny16941/fda-approves-novo-nordisks-awiqli-the-first-and-only-once-weekly-basal-insulin-treatment-for-adults-with-type-2-diabetes