A photo of Zymfentra, Celltrion’s new autoimmune disease treatment, provided by the company (Image courtesy of Yonhap)
SEOUL, Oct. 23 (Korea Bizwire) — South Korea’s major pharmaceutical firm Celltrion Inc. said Monday its new autoimmune disease treatment has won approval from the U.S. Food and Drug Administration (FDA).
The FDA approved Celltrion’s Zymfentra, a subcutaneous injection formulation of its infliximab Remsima, for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following treatment with an infliximab administered intravenously, according to the company.
Celltrion said Zymfentra is the company’s first newly developed drug to get FDA approval and will be under patent protection until 2037 for its dosage form and route of administration until 2040.
The drug has also won approval from drug safety authorities in 50 countries, including Canada and those in Europe, under the brand name Remsima SC.
Zymfentra is expected to garner 600 billion won (US$443.7 million) in annual sales upon its U.S. market debut, according to the company.
Its sales affiliate Celltrion Healthcare Co. will lead marketing and sales of the drug in the United States, the company said.
“The approval of Zymfentra provides an innovative and effective treatment option that offers patients with inflammatory bowel disease an alternative administration option providing control of how and where they receive their treatment,” said Thomas Nusbickel, chief commercial officer at Celltrion USA.
(Yonhap)
