The U.S. Food and Drug Administration (FDA) has granted expanded approval for Johnson
& Johnson’s Tremfya, allowing its use in treating adults with chronic inflammatory bowel
disease (IBD), specifically ulcerative colitis. This marks a significant development, providing
an additional treatment option for those suffering from the condition, which causes painful
inflammation and ulcers in the colon and rectum.
Tremfya has been a key focus for J&J as the company prepares for its other leading drug,
Stelara, to face a patent cliff. When a drug loses its patent protection, it opens the door for
less expensive biosimilars to enter the market, impacting overall sales. Tremfya, which
targets IL-23, a protein involved in immune responses that contribute to inflammation, has
demonstrated positive results in clinical trials. In a late-stage study, patients treated with
Tremfya achieved endoscopic remission, a state where no inflammation or ulcers are visible
during an endoscopic examination.
Chris Gasink, a senior leader in J&J’s U.S. Medical Affairs, confirmed that the company
would make Tremfya available to eligible patients within “a week or two” following the
FDA’s approval. This quick availability could benefit those seeking alternative treatment
options for managing ulcerative colitis. Industry analysts estimate that Stelara’s sales will
surpass $10 billion this year, with approximately 75% coming from treatments for IBD,
making Tremfya a key part of J&J’s strategy moving forward. The drug is now the fourth
treatment J&J has launched for ulcerative colitis, positioning the company in a highly
competitive market that includes other pharmaceutical giants like AbbVie and Eli Lilly.
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