Humira is also indicated for reducing the signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab, the only other approved biologic for treatment of Crohn's disease.
Crohn's disease is a serious chronic, inflammatory disease of the gastrointestinal tract. Common symptoms of Crohn's disease include diarrhea, cramping, abdominal pain, weight loss, fever, and in some cases, rectal bleeding.
Humira also comes with the strongest possible warning because the drug has been associated with serious infections, sepsis, tuberculosis and opportunistic infections, including fatalities.
This approval establishes Humira as the first and only self-administered biologic for the treatment of Crohn's disease. Crohn's disease is the fourth FDA approval in immune-mediated diseases for Humira.
“The approval in Crohn's disease extends the reach of Humira beyond rheumatology and dermatology to an underserved patient population in gastroenterology,” said Eugene Sun, vice president, Global Pharmaceutical Clinical Development at Abbott.
“In addition to rapid and sustained response, Humira offers patients with moderate to severe Crohn's disease the convenience of self-injection in the comfort of their home.”