FDA Approves New Drug For Crohn's Disease Treatment

Armen Hareyan's picture

FDA has issued approval to UCB Inc's new drug Cimzia for Crohn's disease treatment, but the agency has also reported serious adverse side effects.

UCB Inc is a Belgian drug making company that was seeking approval for Cimzia last year, but the company was requested for additional data and research for the drug.


Now the drug has received approval for treatment of moderate and severe types of the disease. These patients do not benefit from other treatments and they need another approach and another treatment.

Inflammatory bowel disease often called Crohn's disease is a chronic condition affecting about 1 million people worldwide. Among common symptoms of this disease health professionals mention 'diarrhea, fever, rectal bleeding, cramping and abdominal pain'.

Cimzia is currently participated in a short-term trial, this is why FDA has not approved it yet for long-term use. UCB will be required to conduct more studies to ensure the drug's safety for long-term use.

FDA has issued a report about the possibility of serious side effects leading to death. So far the agency reported side effects, such as 'headache, upper respiratory infections, abdominal pain and nausea'. However, despite of serious adverse side effects, the drug will be used by many patients suffering from Crohn's disease, because the patients with moderate and severe type of the disease have no alternative treatment for the disease.