FDA Drug Approval Decisions Expected in March 2026

The FDA is expected to make approval decisions on five drug applications in March 2026, with PDUFA dates ranging from March 6 to March 28. The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA) and making a final decision on marketing approval. The typical period for review is 10 months after the drug application has been accepted by the Agency. For drugs that have Priority Review, the review period is reduced to 6 months from the time of application acceptance.

The FDA is expected to decide on the supplemental NDA for deucravacitinib for the treatment of adults with active psoriatic arthritis (PsA) on March 6, 2026. The application is supported by data from the randomized, double-blind phase 3 POETYK PsA-1 (ClinicalTrials.gov Identifier: NCT04908202) and POETYK PsA-2 (ClinicalTrials.gov Identifier: NCT04908189) trials. POETYK PsA-1 evaluated deucravacitinib in patients with active PsA not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD), while POETYK PsA-2 included patients with active PsA who were bDMARD naïve or who had prior tumor necrosis factor alpha inhibitor treatment.

Findings showed both studies met the primary endpoint with a significantly greater percentage of deucravactinib-treated patients achieving American College of Rheumatology improvement of 20% (ACR20) response vs placebo at week 16. Outcomes through week 52 showed clinical response improved and was maintained in patients who continued to receive deucravacitinib. If approved, deucravacitinib would be the first selective tyrosine kinase 2 inhibitor for the treatment of PsA. Deucravacitinib is currently indicated for the treatment of moderate to severe plaque psoriasis under the brand name Sotyktu®.

Reproxalap, a first-in-class small-molecule modulator of reactive aldehyde species (RASP), is under review for the treatment of the signs and symptoms of dry eye disease, with a PDUFA date of March 16, 2026. It works by covalently binding to free aldehydes and diminishing excessive RASP levels, which are generally elevated in ocular and systemic inflammatory disease. The NDA submission includes efficacy and safety data from multiple trials, including the phase 3 TRANQUILITY-2 study (ClinicalTrials.gov Identifier: NCT05062330) and a phase 3, double-masked, vehicle-controlled dry eye chamber challenge trial (ClinicalTrials.gov Identifier: NCT06493604). Findings from these trials showed treatment with reproxalap improved tear production and ocular discomfort in patients with dry eye disease compared with placebo. Instillation site irritation was the most commonly reported adverse event. A dry eye disease field trial was supportive of the activity of reproxalap relative to vehicle, however, it did not achieve statistical significance.

The supplemental NDA for setmelanotide is currently under review for the treatment of acquired hypothalamic obesity, a rare form of obesity that occurs due to injury to the hypothalamus, with a PDUFA date of March 20, 2026. Setmelanotide, a melanocortin-4 receptor agonist, is currently indicated under the brand name Imcivree® to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome or pro-opiomelanocortin, proprotein convertase subtilisin/kexin type 1, or leptin receptor deficiency. The application for acquired hypothalamic obesity is supported by data from the randomized, double-blind, placebo-controlled phase 3 TRANSCEND trial (ClinicalTrials.gov Identifier: NCT05774756). Findings showed treatment with setmelanotide resulted in a statistically significant and clinically meaningful reduction in body mass index compared with placebo (-16.5% vs +3.3%, respectively; placebo-adjusted difference: -19.8%; P <.0001).

The NDA for linerixibat is being reviewed for the treatment of cholestatic pruritus in patients with primary biliary cholangitis (PBC), with a PDUFA date of March 24, 2026. Linerixibat is an investigational inhibitor of the ileal bile acid transporter. The NDA is supported by data from the phase 3 GLISTEN study (ClinicalTrials.gov Identifier: NCT04950127), which included 238 adult PBC patients with cholestatic pruritus. Findings showed treatment with oral linerixibat led to a statistically significant improvement in pruritus compared with placebo (primary endpoint; least squares mean difference, -0.72 [95% CI, -1.15, -0.28]; P =.001). Linerixibat was also associated with significant improvements in key secondary endpoints vs placebo, including itch score at week 2 (P <.001) and itch-related sleep interference over 24 weeks (P =.024).

Marnetegragene autotemcel is under FDA review for severe leukocyte adhesion deficiency-I, with a PDUFA date of March 28, 2026.