FDA Action Alert: Viela, Merck, Epizyme, Evoke and Regeneron
The next two weeks are busy ones for the U.S. Food and Drug Administration (FDA). Here’s a look at PDUFA dates for this period.
Viela Bio’s Inebilizumab for NMOSD
Gaithersburg, Maryland-based Viela Bio has a target action date of June 11 for its Biologics License Application (BLA) for inebilizumab for neuromyelitis optica spectrum disorder (NMOSD). The drug has previously received Orphan Drug and Breakthrough Therapy designations from the FDA.
Inebilizumab, Viela Bio’s lead product, is a humanized monoclonal antibody that targets and depletes CD-19-expressing B-cells. The byproduct of the B-cells, called plasmablasts, make up the autoantibody pathway, which can lead to severe autoimmune diseases like NMSOD.
In the N-Momentum pivotal clinical trial of the drug, it showed a significant reduction in risk of NMOSD attack and on measurements of worsening disability, hospitalizations and new central nervous system MRI lesions. The company also has plans to evaluate the drug in other autoimmune diseases, including myasthenia gravis, IgG4-related disease and kidney transplant desensitization.
Yet Another Merck Indication for its Checkpoint Inhibitor Keytruda
Merck has a target action date of June 16 for its supplemental BLA (sBLA) for Keytruda (pembrolizumab) for adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) greater than or equal to 10 mutations per megabase, as determined by an FDA-approved test, who have progressed after previous treatment and who have no satisfactory alternative treatment options. The application was partially based on data from the Phase II KEYNOTE-158 trial. Keytruda is involved in more than 1,000 clinical trials alone or in combinations in a broad range of cancer indications.
Epizyme’s Tazverik for Follicular Lymphoma
Cambridge, Massachusetts-based Epizyme has a target action date of June 18 for Priority Review of its supplemental New Drug Application (sNDA) of Tazverik (tazemetostat) for relapsed or refractory follicular lymphoma (FL) patients who have had at least two previous lines of systemic therapy. Tazverik is a methyltransferase inhibitor approved for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. It was approved for that indication in January 2020.
“Follicular lymphoma is an incurable disease for which patients are in need of a safe, durable treatment option,” said Shefali Agarwal, chief medical officer of Epizyme in February. “If approved, we believe Tazverik could become an important new option for these patients and their physicians.”
Evoke Pharma’s Gimotti for Recurrent Diabetic Gastroparesis
Solana Beach, California-based Evoke Pharma has a target action date of June 19 for its resubmission of its 505(b)(2) NDA for Gimoti. Gimoti is the company’s nasal spray for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis. Gastroparesis is a debilitating, episodic condition marked by slow or delayed gastric emptying of the stomach’s contents after meals. It often causes nausea, vomiting, abdominal pain and bloating. It is much more common in women.
On May 20, Evoke indicated the FDA had conditionally accepted the brand name of Gimoti.
“Gimoti’s nasal spray delivery is designed to facilitate drug absorption by allowing Gimoti to bypass the dysfunctional GI tract in patients with this disease,” said Dave Gonyer, president and chief executive officer of Evoke. “We continue to believe Gimoti, if approved, will provide an important new product that has the potential to help treat patients suffering from gastroparesis.”
Nabriva’s Contepo for Complicated Urinary Tract Infections
Dublin, Ireland-based Nabriva Therapeutics has a target action date of June 19 for its NDA resubmission for Contepo (Fosfomycin) for the treatment of complicated urinary tract infections (cUTIs). Contepo is a potential first-in-class intravenous antibiotic in the U.S. for cUTIs. The NDA resubmission is supported by data from a pivotal Phase II/III ZEUS trial, which met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with cUTI, including acute pyelonephritis.
Regeneron’s Dupixent 300 mg Auto-Injector
Regeneron Pharmaceuticals has a target action date of June 20 for its sBLA for the 300 mg auto-injector for Dupixent (dupilumab). Dupixent is a subcutaneous injection indicated for various allergic and inflammatory diseases, including children age 12 years or older with moderate-to-severe atopic dermatitis; maintenance treatment with other asthma medicines for moderate-to-severe eosinophilic or oral steroid dependent asthma in patients aged 12 years and older; maintenance treatment of CRSwNP in adults. It is also being evaluated for a broad range of clinical programs for allergic and type 2 inflammatory conditions, including pediatric asthma, pediatric atopic dermatitis, eosinophilic esophagitis, chronic obstructive pulmonary disease, bullous pemphigoid, prurigo nodularis, chronic spontaneous urticaria, and food and environmental allergies. The drug is being jointly developed by Regeneron and Sanofi.
On May 26, the FDA approved Dupixent for children aged 6 to 11 years with moderate-to-severe atopic dermatitis.
“This approval brings the paradigm-changing efficacy and established safety profile of Dupixent to children with moderate-to-severe atopic dermatitis,” said George D. Yancopoulos, co-founder, president and chief scientific officer of Regeneron. “This young, vulnerable population struggles with debilitating symptoms and disease covering over half of their body, impacting them and their families who spend countless hours helping them manage their disease.”