Novo Nordisk Submits CagriSema NDA to FDA; Takeda’s Zasocitinib Meets Dual Primary Endpoints in Two Phase 3 Trials

Novo Nordisk Submits CagriSema for FDA Approval

Novo Nordisk announced today that it has submitted a New Drug Application (NDA) for CagriSema to the U.S. FDA. The therapy is intended to be used in combination with a reduced-calorie diet and increased physical activity for obese or overweight adult patients with at least one weight-related comorbidity, aiming to reduce body weight and maintain long-term weight loss. CagriSema is a fixed-dose combination therapy consisting of the long-acting amylin analog cagrilintide (2.4 mg) and semaglutide (2.4 mg), designed for once-weekly subcutaneous injection. According to the press release,If approved, CagriSema will become the first injectable combination therapy of a GLP-1 receptor agonist and an amylin analog.

This NDA is primarily based on the results of two Phase 3 studies: REDEFINE 1 and REDEFINE 2. The results of the REDEFINE 1 trial showed that,Regardless of whether patients continued medication, the CagriSema group achieved a 20.4% weight reduction (mean baseline weight 236 lbs) at week 68, compared to 3.0% in the placebo group (mean baseline weight 235 lbs), with a statistically significant difference.Assuming all patients continued their medication, the CagriSema group experienced a 22.7% reduction in body weight at week 68, compared to 2.3% in the placebo group. Additionally, 91.9% of participants in the CagriSema group achieved a weight loss of 5% or more, versus 31.5% in the placebo group.

Takeda's Next-Gen Small Molecule Therapy Hits Dual Primary Endpoints in Two Phase 3 Trials

Takeda announced today that its next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor zasocitinib (TAK-279) achieved positive topline results in two pivotal Phase 3 studies conducted in adult patients with moderate to severe plaque psoriasis (PsO). Both trials were randomized, multicenter, double-blind studies with placebo and active drug controls. The results showed,At Week 16, zasocitinib was superior to placebo in the co-primary endpoints of static Physician Global Assessment (sPGA) 0/1 and at least 75% improvement in Psoriasis Area and Severity Index (PASI 75).

In addition to the primary endpoint, the study also showed,The advantage of zasocitinib in PASI 75 response rate was evident as early as Week 4 and continued to increase during subsequent follow-ups until Week 24.Both studies simultaneously met all 44 tiered endpoints, including PASI 90, PASI 100, and sPGA 0 metrics compared to placebo as well as active comparator drugs, indicating that this therapy has the potential to help some patients achieve treatment goals closer to "complete skin clearance." In terms of safety, zasocitinib was generally well-tolerated, with a safety profile consistent with previous clinical studies.

FDA Approves Johnson & Johnson's Cancer Bispecific Antibody Subcutaneous Formulation

Johnson & Johnson recently announced that the U.S. FDA has approved Rybrevant Faspro (amivantamab and hyaluronidase), a subcutaneous formulation of the humanized EGFR/MET-targeted bispecific antibody, for all indications previously approved for Rybrevant (amivantamab). According to the press release, Rybrevant Faspro is the first subcutaneous (SC) administration therapy for patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The press release also noted,Rybrevant Faspro can reduce the administration time from hours to minutes and significantly decrease administration-related adverse reactions.

This approval is mainly based on the results of the Phase 3 PALOMA-3 study. The analysis shows that Rybrevant Faspro is consistent with Rybrevant in terms of efficacy and medication consistency, and has achieved two co-primary pharmacokinetic (PK) endpoints. These endpoints are based on the drug activity in the blood.IngredientsThe drug concentration of amivantamab was measured, including the trough concentration (Ctrough) on Day 1 of Cycle 2 or Day 1 of Cycle 4, and the area under the curve (AUC D1–D15) from Day 1 to Day 15 after dosing in Cycle 2.

References:

[1] Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP‑1 and amylin analogues for weight management. Retrieved December 18, 2025 from https://www.prnewswire.com/news-releases/novo-nordisk-files-for-fda-approval-of-cagrisema-the-first-once-weekly-combination-of-glp1-and-amylin-analogues-for-weight-management-302645868.html

[2] Takeda’s Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment. Retrieved December 18, 2025 from https://www.businesswire.com/news/home/20251218728397/en/Takedas-Zasocitinib-Landmark-Phase-3-Plaque-Psoriasis-Data-Show-Promise-to-Deliver-Clear-Skin-in-a-Once-Daily-Pill-Catalyzing-a-New-Era-of-Treatment

[3] U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when Combined with LAZCLUZE® (lazertinib). Retrieved December 18, 2025 from https://www.prnewswire.com/news-releases/us-fda-approval-of-rybrevant-faspro-amivantamab-and-hyaluronidase-lpuj-enables-the-simplest-shortest-administration-time-for-a-first-line-combination-regimen-when-combined-with-lazcluze-lazertinib-302645263.html

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