FDA Expected to Approve Five New Drugs in May 2026

▎WuXi

Edited by Kant Content Team

According to the anticipated goal date of PDUFA, the U.S. FDA is expected to make regulatory decisions on the approval of two innovative drugs in January. Meanwhile, BioSpace, an industry media outlet, has also announced five highly anticipated regulatory decisions by the U.S. FDA in the first quarter of this year. Today, the content team at WuXi AppTec will provide relevant introductions to these therapies based on publicly available information.

Possibly obtained in January 2024FDA-Approved Innovative Drugs

▲1

New drugs that may be approved by the U.S. FDA in the coming month (

Source of the chart:

(WuXi AppTec Content Team Chart)

Therapy: Berdazimer

Company:

Novan

PDUFA Date:

January 5, 2024

By

Novan

The developed 10.3% berdazimer gel (SB206) is a topical antiviral gel for the treatment of viral skin infections, with the potential to become the "first-in-class" topical therapy for molluscum contagiosum. The active ingredient, berdazimer, is a new chemical entity (NCE) that releases nitric oxide (NO) and exhibits antiviral activity. In a pivotal Phase 3 clinical study named B-SIMPLE4, researchers evaluated the safety and efficacy of berdazimer in treating molluscum contagiosum. Results showed a statistically significant improvement in the primary endpoint (p<0.001), with patients achieving complete lesion clearance after 12 weeks of treatment. Additionally, the study demonstrated that the therapy has a favorable safety profile, with no drug-related serious adverse events reported.

Image Source: 123RF

Therapy:

Zolbetuximab

Company:

Astellas Pharma

PDUFA Date:

January 12, 2024

Zolbetuximab is an IgG1 monoclonal antibody that specifically binds to CLDN18.2 on the surface of tumor cells to exert its antitumor effects.

Preclinical studies have shown that this binding effect induces cancer cell death by activating two different immune system pathways—antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC)—with the aim of achieving tumor treatment. Zolbetuximab has been granted priority review by the FDA as a first-line treatment for CLDN18.2-positive locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma patients. In January last year, Astellas announced the results of the SPOTLIGHT trial.

Results showed that, compared to patients receiving placebo plus the mFOLFOX6 chemotherapy regimen, patients treated with zolbetuximab in combination with the mFOLFOX6 chemotherapy regimen demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS). The risk of disease progression and death was significantly reduced by 24.9% in the experimental group compared to the placebo group, achieving the primary endpoint of the trial. The median progression-free survival for patients receiving the zolbetuximab combination therapy was 10.61 months (vs. 8.67 months), and overall survival was also extended, with a median overall survival of 18.23 months (vs. 15.54 months). The incidence of severe treatment-related adverse reactions was similar between the two groups, at 44.8% and 43.5%, respectively, consistent with previous trial results.

5 Key Regulatory Decisions by the FDA in the First Quarter of 2024

▲2024 Year

Overview of the 5 Most Notable FDA Regulatory Decisions in the First Quarter (Chart Source: WuXi AppTec Content Team, reorganized and tabulated based on Reference [1])

Therapy:

Lifileucel

Company:

IovanceBiotherapeutics

PDUFA Date:

February 24, 2024

Lifileucel is a cell therapy constructed based on the patient's own tumor-infiltrating lymphocytes (TIL).

These TILs migrate to the tumor site and attack the tumor when cancer occurs. However, the number of TILs in patients is usually insufficient to eliminate the tumor, and the tumor microenvironment suppresses the function of TILs. This therapy involves obtaining tumor tissue from the patient and extracting TILs, then using IL-2 cytokines to stimulate the expansion of TILs in vitro. This in vitro stimulation not only increases the number of TILs but also activates their anti-tumor capabilities. These TILs are then reinfused into the patient to more effectively kill tumor cells. Clinical trial results show that a single injection of lifileucel can achieve an overall response rate of 34.3% in refractory melanoma patients who have received PD-1 inhibitors and BRAF/MEK targeted therapies. If approved, it will not only become the first TIL therapy to be launched but also the first T-cell therapy approved for treating solid tumors, potentially becoming another milestone in cell therapy.

Reference Reading:35-Year Marathon! Potential Cure for Solid Tumors, This Cell Therapy Reaches Key Milestone

Therapy:

Roluperidone

Company:

MinervaNeurosciences

PDUFA Date:

February 26, 2024

Schizophrenia is a chronic mental disorder that affects how a person thinks, feels, and behaves. The disease includes positive symptoms (hallucinations, delusions), negative symptoms (difficulty enjoying life, social withdrawal), and cognitive impairments. Roluperidone is an investigational small molecule antagonist being developed to treat the negative symptoms of schizophrenia. This therapy has been shown to block serotonin, sigma, and α-adrenergic receptors, all of which are involved in regulating key brain functions, including mood, cognition, sleep, and anxiety. Roluperidone is designed to avoid directly blocking dopaminergic receptors (the key pharmacological target of first- and second-generation antipsychotics) while maintaining blockade of specific subtypes of serotonin receptors, 5-HT2A (another key target of second-generation antipsychotics), as well as other pharmacological targets (sigma2 and adrenergic-α1A).

Therapy:

GADepot

Company:

MapiPharma &Viatris

PDUFA Date:

March 8, 2024

GA Depot is a long-acting injectable formulation of glatiramer acetate (brand name Copaxone) developed by MapiPharma. The treatment regimen involves intramuscular injections once every four weeks for a total of 13 injections, indicated for the treatment of relapsing-remitting multiple sclerosis (RMS). Results from the Phase 3 clinical trial demonstrated that the study met its primary endpoint, with GA Depot reducing the annualized relapse rate by 30.1% compared to the placebo group.

Image Source: 123RF

Therapy:

Resmetirom

Company:

MadrigalPharmaceuticals

PDUFA Date:

March 14, 2024

Resmetirom is a once-daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target the key underlying causes of non-alcoholic steatohepatitis (NASH).

Thyroid hormones play a central role in liver function by activating β-receptors in hepatocytes, influencing a range of health parameters from serum cholesterol and triglyceride levels to the pathological accumulation of fat in the liver. Resmetirom is highly selective, avoiding the activation of THR-α receptors that mediate thyroid hormone activity outside the liver (including in the heart and bones), and is specifically taken up in the liver. In clinical trials, the vast majority (>70%) of patients treated with 100 mg of resmetirom achieved ≥30% proton density fat fraction (MRI-PDFF) reduction. Notably, a ≥30% reduction in MRI-PDFF was closely associated with NASH resolution (96% of patients) and fibrosis improvement (88% of patients). In September 2023, the U.S. FDA granted this therapyPriority Review Status

。

▲

Efficacy Results of the MAESTRO-NASH Trial (Source: Reference [2])

Therapy:

Casgevy（exagamglogeneautotemcel，exa-cel）

Company:

VertexPharmaceuticals & CRISPR Therapeutics

PDUFA Date:

March 30, 2024

Casgevy was approved on December 8 last year.FDA Approval

Used to treat patients aged 12 and above with sickle cell disease (SCD) suffering from recurrent vaso-occlusive crises, this is the first CRISPR gene-editing therapy approved by the FDA. However, the FDA is still reviewing the application for this therapy to treat patients with transfusion-dependent beta-thalassemia (TDT), with the review results expected to be announced before March 30. In November 2023, the UK Medicines and Healthcare products Regulatory Agency (MHRA) granted CasgevyConditional Marketing Authorization

, for the treatment of SCD and TDT patients. According to Vertex's announcement, Casgevy received a recommendation from the European Medicines Agency (EMA) Committee for Human Medicinal Products (CHMP) in December last year for the treatment of these two diseases, and the EMA is expected to make a final regulatory decision on these two indications in February. In the global clinical trial of Casgevy for the treatment of TDT patients, the primary endpoint was achieved. Among the 44 TDT patients who received the treatment, 42 no longer required transfusions after a follow-up period of 1.2-37.2 months, while the remaining two patients experienced reductions in transfusion levels by 75% and 89%, respectively.

▲ Clinical trial data of TDT patients treated with exa-cel (Image source:

CRISPR Therapeutics Official Website)

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References:

[1] 5 FDA Decisions to Watch in Q1. Retrieved January 2,2024 from https://www.biospace.com/article/5-fda-decisions-to-watch-in-q1-2024/

[2] Primary Results From MAESTRO-NASH: A Pivotal Phase 3 52-week Serial Liver Biopsy Study in 966 Patients With NASH & Fibrosis. Retrieved November 10, 2023 from https://ir.madrigalpharma.com/static-files/e8a35f47-f841-49d4-9c21-781f41177609

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div.autoTypeSetting24psection > p,div.autoTypeSetting24psection > section{margin-bottom: 24px;}