FDA PDUFA Dates: 6 Drug Reviews Scheduled for June
FDA PDUFA dates set for June represent one of the busiest review periods of the year for the U.S. Food and Drug Administration. Six biologics and drug applications are scheduled for action decisions within a two week window, spanning therapeutic areas from rare neurological diseases to oncology, infectious disease, and inflammatory conditions. Here is a closer look at each candidate under review.
Viela Bio’s Inebilizumab for NMOSD — June 11
Viela Bio, based in Gaithersburg, Maryland, has a target action date of June 11 for its Biologics License Application for inebilizumab, a treatment for neuromyelitis optica spectrum disorder (NMOSD). The drug has previously received both Orphan Drug and Breakthrough Therapy designations from the FDA.
Inebilizumab is a humanized monoclonal antibody that targets and depletes CD19 expressing B cells. In the N-Momentum pivotal clinical trial, the drug demonstrated a significant reduction in risk of NMOSD attack as well as improvements in disability progression, hospitalizations, and central nervous system MRI lesion counts. Viela Bio also plans to evaluate the therapy in other autoimmune conditions including myasthenia gravis and IgG4 related disease.
Merck’s Keytruda for TMB-H Solid Tumors — June 16
Merck has a target action date of June 16 for a supplemental BLA for Keytruda (pembrolizumab) in adult and pediatric patients with unresectable or metastatic solid tumors with high tissue tumor mutational burden, defined as 10 or more mutations per megabase, who have progressed after prior treatment and have no satisfactory alternatives. The application draws on data from the Phase II KEYNOTE-158 trial. Keytruda is currently involved in more than 1,000 clinical trials across a broad range of cancer indications.
Epizyme’s Tazverik for Follicular Lymphoma — June 18
Cambridge, Massachusetts based Epizyme has a Priority Review target action date of June 18 for a supplemental NDA for Tazverik (tazemetostat) in relapsed or refractory follicular lymphoma patients who have received at least two prior lines of systemic therapy. Tazverik is a methyltransferase inhibitor already approved for epithelioid sarcoma. Follicular lymphoma remains an incurable disease, and Epizyme has positioned Tazverik as a durable treatment option for patients with limited remaining choices.
Evoke Pharma’s Gimoti for Diabetic Gastroparesis — June 19
Solana Beach, California based Evoke Pharma has a target action date of June 19 for its resubmission of a 505(b)(2) NDA for Gimoti, a nasal spray formulation for adult women with acute and recurrent diabetic gastroparesis. Gastroparesis is a debilitating condition marked by delayed gastric emptying, causing nausea, vomiting, abdominal pain, and bloating. The nasal delivery route is designed to bypass the dysfunctional gastrointestinal tract, potentially improving drug absorption in this patient population.
Nabriva’s Contepo for Complicated Urinary Tract Infections — June 19
Dublin based Nabriva Therapeutics also has a June 19 target action date for its NDA resubmission for Contepo (fosfomycin), a potential first in class intravenous antibiotic for complicated urinary tract infections in the U.S. The resubmission is supported by data from the pivotal Phase II/III ZEUS trial, which met its primary endpoint of statistical non inferiority to piperacillin/tazobactam in patients with complicated UTI including acute pyelonephritis.
Regeneron’s Dupixent Auto-Injector — June 20
Regeneron Pharmaceuticals has a target action date of June 20 for a supplemental BLA for a 300 mg auto injector formulation of Dupixent (dupilumab). Dupixent is already approved for multiple allergic and inflammatory conditions including moderate to severe atopic dermatitis, eosinophilic asthma, and chronic rhinosinusitis with nasal polyps. The FDA recently approved Dupixent for children aged 6 to 11 years with moderate to severe atopic dermatitis, expanding its reach to a younger patient population with significant unmet need.
The Role of Clinical Trials Behind Every FDA Decision
Each of the candidates facing FDA PDUFA dates this June reached this stage only after completing a rigorous multi phase clinical trial program. Phase I through Phase III studies generate the safety, immunogenicity, and efficacy data that regulators require before granting approval. Research networks capable of enrolling diverse patient populations across multiple indications are essential to this process. FOMAT supports sponsors and CROs across the United States in conducting Phase I through Phase IV clinical trials, helping advance promising therapies toward the patients who need them.
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