Johnson & Johnson’s anti-inflammatory drug, Remicade (infliximab), has been granted priority review status in the USA for the treatment of ulcerative colitis – meaning that the country’s Food and Drug Administration will review the product’s potential new use over a six month period, versus the usual twelve month timeframe.
The firm notes that there are currently no FDA-approved therapies to treat moderately-to-severely active UC – a chronic inflammatory bowel disease affecting nearly 500,000 people in the US alone, which may cause patients to face surgical removal of the colon. The drug is indicated for the treatment of Crohn’s disease – another difficult-to-treat inflammatory bowel disease.
Priority review designation is granted by the FDA to products that are considered to be a potential therapeutic advance over current therapies. J&J’s partner, Centocor, filed the dossier for Remicade in US in March this year, based on data from the so-called Act 1 and Act 2 clinical trials. In these studies, 62% to 69% of the patients treated with Remicade showed significant improvement in their symptoms after eight weeks of treatment.