FDA Roundup: Humira Biosimilar, WHIM Syndrome Treatment

FDA Approves Second Formulation of Humira Biosimilar Cyltezo

The FDA approved Boehringer Ingelheim’s adalimumab-adbm (Cyltezo), a high-concentration, citrate-free, interchangeable Humira (adalimumab; AbbVie) biosimilar to treat several chronic inflammatory diseases.

Adalimumab-adbm is indicated to reduce the signs and symptoms of moderate-to-severe rheumatoid arthritis in adults; moderate-to-severe polyarticular juvenile idiopathic arthritis in children 2 years and older; psoriatic arthritis in adults; ankylosing spondylitis in adults; and moderate-to-severe hidradenitis suppurativa in adults. It is further indicated to treat moderate-to-severe Crohn’s disease in adults and children 6 years of age and older; moderate-to-severe ulcerative colitis in adults; moderate-to-severe chronic plaque psoriasis in adults; and non-infectious intermediate, posterior, and panuveitis in adults.

The FDA approval was partially supported by positive data from VOLTAIRE-HCLF (NCT05203289), a phase 1 clinical trial that compared the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm. The approval of adalimumab-adbm, along with the previously established interchangeability of Cyltezo, represents a significant step towards improving affordability and accessibility of adalimumab treatment for patients in the US.

READ MORE: Brexpiprazole Plus Sertraline for PTSD Submitted to FDA for sNDA Review

FDA Approves Mavorixafor for Treatment of WHIM Syndrome

The FDA approved mavorixafor (Xolremdi) to treat warts, hypogammaglobulinemia, infections and myelokathexi (WHIM) syndrome in patients 12 years of age or older. X4 Pharmaceuticals’ Mavorixafor is the first approved therapy that’s specifically indicated for patients with the rare inherited immunodeficiency disease.

The approval of mavorixafor was based on data from the 4WHIM trial (NCT03995108), in which the therapy met its primary endpoint of time above threshold for absolute neutrophil count versus placebo. Mavorixafor treatment also resulted in reductions in the rate, severity, and duration of infections, and was generally well-tolerated with no treatment-related serious adverse events.

WHIM syndrome is characterized by low levels of neutrophils and lymphocytes in the blood due to dysfunction in the CXCR4 receptor, which results in serious and frequent infections. There are currently around 1000 patients in the United States diagnosed with the disease. Mavorixafor is a small-molecule selective CXCR4 receptor antagonist that helps to increase the mobilization of neutrophils and lymphocytes from the bone marrow into peripheral circulation.

FDA Approves Tisotumab Vedotin for Recurrent or Metastatic Cervical Cancer

The FDA gave full approval to tisotumab vedotin-tftv (Tivdak) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.¹ The therapy had originally been granted accelerated approval in 2021.

The approval was based on data from the innovaTV 301 (NCT04697628) study, a phase 3, open-label, active-controlled, multicenter, randomized trial to determine if tisotumab vedotin works better than chemotherapy to treat cervical cancer. The study cohort included 502 patients with recurrent or metastatic cervical cancer who had received 1 or 2 prior systemic regimens. Tisotumab vedotin demonstrated an overall survival rate of 11.5 months, compared to 9.5 months for chemotherapy. Median progression free survival was 4.2 months and confirmed objective response rate was 17.8%.

The most common adverse reactions to tisotumab vedotin-tftv included decreased hemoglobin, peripheral neuropathy, conjunctival adverse reactions, increased aspartate aminotransferase, nausea, increased alanine aminotransferase, fatigue, decreased sodium, epistaxis, and constipation.

FDA Accepts sNDA for Tapinarof Cream 1% for Treatment of Atopic Dermatitis

The FDA accepted a supplemental new drug application (sNDA) for tapinarof (Vtama) cream, 1% for the topical treatment of atopic dermatitis (AD) in adults and children 2 years of age and older. The treatment was p[previously approved by the FDA to treat plaque psoriasis in adults.

The application was supported by data from the phase 3, identical, double-blind, randomized, vehicle-controlled, pivotal ADORING 1 (NCT05014568) and ADORING 2 (NCT05032859) trials, as well as interim analysis results of the ADORING 3 (NCT05142774) phase 3 development program. The FDA has assigned a PDUFA date in quarter 4 of 2024 for the company’s sNDA application.

READ MORE: FDA Updates Resource Center

Reference

1. FDA approves tisotumab vedotin-tftv for recurrent or metastatic cervical cancer. News Release. FDA. April 29, 2024. Accessed May 3, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer