FDA approves Zymfentra as first subcutaneous infliximab for ulcerative colitis, Crohn’s
The FDA approved the subcutaneous formulation of Celltrion USA’s Zymfentra as maintenance therapy for patients with moderately-to-severely active ulcerative colitis and Crohn’s disease following induction with IV administered infliximab.
Zymfentra (infliximab-dyyb) is now “the first and only” subcutaneous formulation of infliximab approved for this indication, according to a company press release. The IV formulation of the Celltrion’s infliximab biosimilar was originally approved by the EU in 2013 under the name Remsima for the treatment of eight autoimmune diseases, including Crohn’s disease and ulcerative colitis, and later approved by the FDA in 2016. In the U.S., it is manufactured by Celltrion and marketed by Pfizer as Inflectra.
“There remains an unmet need for patients who suffer from the day-to-day burden of living with moderately-to-severely active Crohn’s disease and ulcerative colitis,” Thomas Nusbickel, chief commercial officer at Celltrion USA, said in the release. “The approval of Zymfentra provides an innovative and effective treatment option that offers patients with IBD an alternative administration option providing control of how and where they receive their treatment, reinforcing our commitment to providing high-quality and affordable treatment options that deliver substantial value to patients and our health care system.”
The FDA based its decision on data from the randomized, double-blind, phase 3 LIBERTY UC and LIBERTY CD trials, assessing the efficacy and safety of Zymfentra as maintenance therapy in patients with moderately-to-severely active UC (n=438) and Crohn’s (n=343), following induction of the IV formulation of infliximab over 54 weeks. Compared with placebo, Zymfentra was superior in achieving the primary endpoints of clinical remission and endoscopic response in both trials.
In the LIBERTY UC trial, at week 54, a significantly greater proportion of patients who received Zymfentra achieved clinical remission compared with placebo (43.2% vs, 20.8%; P<0.0001). In the LIBERTY CD trial, a greater proportion of patients who received Zymfentra also achieved clinical remission (62.3% vs. 32.1 %; P<0.0001) and endoscopic response (51.1% vs. 17.9%; P<0.0001) compared with placebo.
Both studies demonstrated a similar safety profile between Zymfentra and placebo, with no new safety signals observed. Between the two trials, the most common adverse events were COVID-19 infection, upper respiratory tract infection, headache, injection site reaction, diarrhea, increased alanine aminotransferase and blood creatine phosphokinase, neutropenia, hypertension, urinary tract infection, dizziness, leukopenia and abdominal pain.
“As a health care professional dedicated to improving the lives of patients with IBD, I am excited to see further data that validate a convenient treatment option that could allow more patients in the U.S. to have greater control of their disease management,” Jean-Frederic Colombel, MD, professor of gastroenterology at the Icahn School of Medicine at Mount Sinai, said in the release.
The company noted the biosimilar will be under patent protection by 2037 for the dosage form and by 2040 for the route of administration.