US FDA expands J&J's psoriasis drug for inflammatory bowel disease

By Sriparna Roy and Bhanvi Satija

(Reuters) -The U.S. Food and Drug Administration has allowed the expanded use of Johnson & Johnson's drug, Tremfya, to treat adults with a type of chronic inflammatory bowel disease, the company said on Wednesday.

The approval paves the way for another treatment option for patients with ulcerative colitis, which causes inflammation and ulcers in the colon and rectum.

Drugmakers such as AbbVie, Eli Lilly and J&J are hustling for a share in an already-crowded, multi-billion market for treatments for inflammatory bowel diseases.

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% are expected from sales for inflammatory bowel diseases.

Tremfya, which targets a protein involved in inflammatory responses called IL-23, will be J&J's fourth drug for ulcerative colitis in the market.

(Reporting by Sriparna Roy, Bhanvi Satija and Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar and Krishna Chandra Eluri)