The approval paves the way for another treatment option for patients with ulcerative colitis, which causes inflammation and ulcers in the colon and rectum.
J&J has been betting on Tremfya, as its other blockbuster drug for psoriasis and ulcerative colitis, Stelara, is looking at a patent cliff – which occurs when a company loses its patent protection, allowing cheaper biosimilars to enter the market.
In a late-stage trial, patients receiving Tremfya were able to achieve endoscopic remission – a state where no signs of inflammation, ulcers or bleeding are visible during an endoscopy.
Chris Gasink, who looks over J&J’s U.S. Medical Affairs said the company was ready to make the drug available to eligible patients within “a week or two” after the FDA’s decision.
Analysts forecast Stelara sales of over $10 billion this year, according to LSEG data, of which 75 per cent are expected from sales for inflammatory bowel diseases.
