The regulator has approved the first-ever subcutaneous version of infliximab, an IgG1 monoclonal antibody, commonly sold by Johnson & Johnson under the brand name Remicade.
Pictured: Exterior of an FDA building/iStock, Grandbrothers
The FDA on Monday approved Celltrion’s subcutaneous formulation of infliximab, now to be marketed under the brand name Zymfentra, for the maintenance therapy of adults with moderate-to-severely active ulcerative colitis and Crohn’s disease.
Zymfentra is the first FDA-authorized subcutaneous formulation of infliximab, according to Celltrion’s announcement. The therapy is indicated for patients who had previously undergone intravenous infliximab treatment.
Infliximab is an IgG1 monoclonal antibody that works by blocking the pro-inflammatory cytokine TNF-alpha, which is known to play a role in driving inflammatory diseases such as ulcerative colitis (UC) and Crohn’s disease (CD). Infliximab was first approved in 1998 and is sold by Johnson & Johnson’s Janssen under the brand name Remicade.
Several Remicade biosimilars have since hit the market, including Amgen’s Avsola and Organon’s Renflexis. Celltrion has its own infliximab biosimilar Inflectra, which was approved in April 2016. Pfizer holds exclusive commercial rights to Inflectra in the U.S. and certain other territories.
Remicade and all of its biosimilars are administered intravenously. Zymfentra, on the other hand, has been reformulated to be available via a subcutaneous injection. Zymfentra was approved as a novel drug based on its own standalone Biologics License Application.
Celltrion USA CEO Thomas Nusbickel said in a statement that Zymfentra’s approval provides patients an alternative treatment option and gives them greater “control of how and where they receive their treatment.”
The company supported its regulatory submission with pivotal data from the Phase III LIBERTY-UC and LIBERTY-CD studies, which together demonstrated that maintenance therapy with Zymfentra induced higher rates of clinical remission than placebo in patients with moderate-to-severe UC and CD, respectively, following induction with intravenous infliximab.
In terms of safety, both studies did not record new signals of concern and found that the frequencies of adverse events were similar to that in the placebo group.
Zymfentra will have patent protections for its dosage form until 2037 and route of administration until 2040, according to Celltrion.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
