By Sriparna Roy and Bhanvi Satija
LONDON: The US Food and Drug Administration has approved Johnson & Johnson’s drug Tremfya for the treatment of chronic inflammatory bowel disease in adults, 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 to gain a share of the already crowded, multibillion-dollar market for treating inflammatory bowel diseases.
J&J is betting on Tremfya as its other blockbuster drug for psoriasis and ulcerative colitis, Stelara, faces a patent cliff — which occurs when a company loses its patent protection, which allows cheaper biosimilars to enter the market. .
In a late-stage trial, patients receiving Tramfya were able to achieve endoscopic remission—a condition where no signs of inflammation, ulcers, or bleeding were seen during endoscopy.
Chris Gassink, who oversees J&J’s US medical affairs, said the company is ready to make the drug available to eligible patients within “a week or two” after the FDA’s decision.
Analysts forecast Stelara sales of more than $10 billion this year, according to LSEG data, with 75 percent of that expected to come from inflammatory bowel disease sales.
Tramfya, which targets a protein involved in inflammatory reactions called IL-23, will be J&J’s fourth drug for ulcerative colitis on the market.
(Reporting by Sriparna Roy, Bhanvi Satija and Puyan Singh in Bengaluru; Editing by Shilpi Majumdar and Krishna Chandra Iluri)
