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Johnson & Johnson’s Stelara receives FDA approval

pharmafile | September 27, 2016 | News story | Manufacturing and Production, Research and Development Janssen Biotech, Johnson & Johnson, Stelara 

The drug is approved for use to treat the skin condition scaly plaque psoriasis and a type of arthritis associated with psoriasis. Crohn’s disease is a chronic inflammatory condition in the gastrointestinal tract, causing abdominal pain, diarrhoea, rectal bleeding, weight loss and fever. It affects about 700,000 Americans and nearly 250,000 Europeans, according to Johnson & Johnson.

Stelara blocks the two inflammation-causing proteins IL-12 and IL-23, and is already one of Johnson & Johnson’s largest revenue generators, with sales of around $2.5 billion in 2015. Late stage trial data showed Stelara caused remissions in moderate-to-severe Crohn’s disease patients who had not improved from treatment with TNF inhibitors, the leading class of drugs for inflammatory bowel disease.

Andrew Greenspan, vice president of medical affairs, released a statement concerning the decision saying: “The approval of STELARA for Crohn’s disease underscores our commitment to provide innovative treatment options for people living with chronic inflammatory and immune-mediated diseases. We are confident STELARA will improve the lives of many people living with Crohn’s disease and are committed to ensuring that it is accessible to patients who qualify for this new therapeutic option.”

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Ben Hargreaves

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