ZYMFENTRA™(infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab, now commercially available in the U.S.
ZYMFENTRA™ is the first FDA-approved subcutaneous infliximab for the treatment of moderately to severely active ulcerative colitis and moderately to severely active Crohn's diseaseZYMFENTRA™ is commercially available across the U.S. on March 15, 2024 JERSEY CITY, N.J., March 17, 2024 /PRNewswire/ -- Celltrion USA announced today the availability of a ZYMFENTRA™ (infliximab-dyyb), a subcutaneous (SC) formulation of infliximab.[1] ZYMFENTRA is the first and only subcutaneous infliximab approved by the U.S. Food and Drug Administration (FDA) in 2023.ZYMFENTRA is approved for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or moderately to severely active Crohn's disease (CD) following an induction treatment regimen with an infliximab product administered intravenously. The recommended dose of ZYMFENTRA for maintenance treatment is 120 mg every two weeks. "Infliximab is a well-established treatment for people living with ulcerative colitis or Crohn's disease," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "The novel subcutaneous administration represents an important advancement in patient care that can offer a convenient treatment option, allowing patients in the U.S. to have greater flexibility in managing their disease." The approval of ZYMFENTRA was based on phase III pivotal data from the LIBERTY-UC and LIBERTY-CD studies. The results of these studies demonstrated ZYMFENTRA's superiority in clinical remission and endoscopic response compared to placebo for maintenance treatment after induction therapy with the intravenous formulation of infliximab in patients with UC and CD over a 54-week study period. The overall safety profile of ZYMFENTRA was similar to that of placebo during maintenance period in both studies, with no new safety signals seen.[2],[3] "The burden of Crohn's disease and ulcerative colitis on patients' daily lives is substantial," said Michael Osso, President and CEO of the Crohn's & Colitis Foundation. "This is a meaningful advancement for eligible adult patients with Crohn's disease and ulcerative colitis, who now have more options and can receive treatment of ZYMFENTRA at home, through subcutaneous delivery, allowing more flexibility and choice." "Patients with ulcerative colitis and Crohn's disease are seeking not only safe and efficacious treatments that can provide incremental improvement but also convenient options when managing these chronic conditions," said Dr. Jean-Frederic Colombel of Icahn School of Medicine at Mount Sinai. "The availability of ZYMFENTRA will further allow patients to have better control of their treatment, providing flexibility and convenience." ZYMFENTRA will be under patent protection through 2037 for its dosage form and route of administration by 2040. About ZYMFENTRA™ (infliximab-dyyb)ZYMFENTRA is a prescription medicine used as an injection under the skin (subcutaneous injection) by adults for the maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product given by intravenous infusion (IV), moderately to severely active Crohn's disease following treatment with an infliximab product given by intravenous infusion (IV). ZYMFENTRA blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and cause the immune system to attack normal, healthy parts of the body.ZYMFENTRA™ (infliximab-dyyb) was approved by the FDA through the Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act (a "stand-alone" BLA). ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040. ZYMFENTRA (infliximab-dyyb) U.S. Use and Important Safety InformationZYMFENTRA is a prescription medicine indicated in adults for maintenance treatment of:moderately to severely active Crohn's disease following treatment with an infliximab product administered intravenously.moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.It is not known if ZYMFENTRA is safe and effective in children under 18 years of age. What is the most important information I should know about ZYMFENTRA? SERIOUS INFECTIONSPatients treated with ZYMFENTRA are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death. Discontinue ZYMFENTRA if a patient develops a serious infection or sepsis.Reported infections include:Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before and during treatment with ZYMFENTRA. Treatment for latent infection should be initiated prior to treatment with ZYMFENTRA.Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients may present with disseminated, rather than localized, disease. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with ZYMFENTRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with ZYMFENTRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy.Risk of infection may be higher in patients greater than 65 years of age, patients with comorbid conditions and/or patients taking concomitant immunosuppressant therapy. In clinical trials, other serious infections observed in patients treated with infliximab included arthritis bacterial, pneumonia, and urinary tract infection. MALIGNANCIESMalignancies, some fatal, have been reported in children, adolescents, and young adults treated with TNF blockers, including infliximab products.Approximately half of these cases were lymphomas, including Hodgkin's and non-Hodgkin's lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.Post-marketing cases of hepatosplenic T-cell lymphoma, a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including infliximab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis, and most were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. Carefully assess the risks and benefits of treatment with ZYMFENTRA, especially in these patient types.In clinical trials of all TNF blockers, more cases of malignancies were observed compared with controls and the expected rate in the general population. In clinical trials of some TNF blockers, including infliximab products, more cases of other malignancies were observed compared with controls. As the potential role of TNF blocker therapy in the development of malignancies is not known, caution should be exercised when considering treatment of patients with a current or a past history of malignancy.Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab products. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. CONTRAINDICATIONSZYMFENTRA is contraindicated in patients with a previous severe hypersensitivity reaction to infliximab-dyyb, other infliximab products, any of the inactive ingredients of ZYMFENTRA or any murine proteins (severe hypersensitivity reactions have included anaphylaxis, hypotension, and serum sickness). HEPATITIS B VIRUS REACTIVATIONTNF blockers, including infliximab products, have been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases were fatal. Patients should be tested for HBV infection before initiating ZYMFENTRA. For patients who test positive, consult a physician with expertise in the treatment of hepatitis B. Exercise caution when prescribing ZYMFENTRA for patients identified as carriers of HBV, and monitor closely for active HBV infection during and following termination of therapy with ZYMFENTRA. Discontinue ZYMFENTRA in patients who develop HBV reactivation and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of ZYMFENTRA, and monitor patients closely. HEPATOTOXICITYHepatobiliary disorders, including acute liver failure, jaundice abnormal hepatic function, hepatic steatosis, hepatitis, hepatotoxicity, hyperbilirubinemia, and non-alcoholic fatty liver, have been reported in patients receiving infliximab products post-marketing. Some cases were fatal or required liver transplant. Aminotransferase elevations were not noted prior to discovery of liver injury in many cases. Patients with symptoms or signs of liver dysfunction should be evaluated for evidence of liver injury. If jaundice and/or marked liver enzyme elevations (eg, ≥5 times the upper limit of normal) develop, ZYMFENTRA should be discontinued, and a thoroug…