FDA Drug Approval Decisions Expected in April 2026

The U.S. Food and Drug Administration is scheduled to make decisions on four drug applications in April 2026, with PDUFA dates ranging from April 6 to April 28. The applications span treatments for blood cancers, obesity, kidney disease, and HIV-1 infection.

The FDA granted Priority Review to the BLA for Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic for the treatment of hematological malignancies including acute myeloid leukemia, acute lymphoblastic leukemia and myelodysplastic syndromes, with a PDUFA date of April 6, 2026. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors. The product is administered after a myeloablative conditioning regimen.

The BLA submission is supported by data from the randomized, open-label, phase 3 PRECISION-T trial, which compared Orca-T with conventional allogeneic hematopoietic stem cell transplant in patients with advanced hematological malignancies. Findings showed the study met its primary endpoint, demonstrating a statistically significantly improvement in survival free of moderate to severe chronic graft vs host disease with Orca-T vs alloHSCT at 1 year (78% vs 38%; hazard ratio, 0.26; P <.00001). Overall survival at 1-year was 94% in the Orca-T arm and 83% in the alloHSCT arm (HR, 0.49; P =.11823). Cumulative incidence of moderate to severe cGvHD was lower in the Orca-T arm vs the alloHSCT arm (13% vs 44%; HR, 0.19; P <.00002). Results from a recent analysis of manufacturing and distribution showed 100% of ordered Orca-T was delivered to transplant centers across the US within 70 hours, with product quality being consistent across all 3 components.

Orforglipron, an oral glucagon-like peptide-1 receptor agonist, is under review for the treatment of adults with obesity or overweight with at least 1 weight-related comorbidity, with a PDUFA date of April 10, 2026. The application is supported by data from the ATTAIN phase 3 clinical trial program. The ATTAIN-1 trial evaluated orforglipron in nondiabetic obese and overweight patients, while the ATTAIN-2 trial assessed the agent in obese and overweight patients with type 2 diabetes. In both studies, statistically significant reductions in body weight were observed with orforglipron when compared with placebo. Orforglipron also demonstrated clinically meaningful improvements across key cardiovascular risk factors.

Orforglipron safety was found to be consistent with other GLP-1 medications. The most common adverse events reported were nausea, vomiting, diarrhea, constipation, and dyspepsia. Results from the phase 3 ATTAIN-MAINTAIN trial also showed that orforglipron was superior to placebo in maintaining body weight reduction in patients who achieved plateau with injectable semaglutide or tirzepatide.

The supplemental NDA for sparsentan is under review for the treatment of focal segmental glomerulosclerosis, a leading cause of end-stage renal disease, with a PDUFA date of April 13, 2026. Sparsentan is an oral endothelin and angiotensin II receptor antagonist currently approved under the brand name Filspari® to slow kidney function decline in adults with primary immunoglobulin A nephropathy who are at risk for disease progression. The submission package for FSGS includes data from the phase 3 DUPLEX study and the phase 2 DUET study.

Findings from these trials showed treatment with sparsentan led to a significant reduction in proteinuria compared with the angiotensin II blocker irbesartan. Data from the DUPLEX study also revealed significantly more sparsentan-treated patients vs irbesartan-treated patients achieved proteinuria levels below 0.7g/g, a clinically meaningful target that has been associated with long-term kidney preservation in patients with FSGS.

The FDA is reviewing the NDA for a new once-daily, 2-drug regimen for the treatment of adults with virologically-suppressed HIV-1 infection, with a PDUFA date of April 28, 2026. The oral therapy combines doravirine, a non-nucleoside reverse transcriptase inhibitor, with islatravir, a nucleoside reverse transcriptase translocation inhibitor, in a single tablet.

The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a New Drug Application or Biologics License Application 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.