AbbVie (ABBV, Financial) announced through PR Newswire Wednesday that risankizumab (ABBV-066; formerly BI 655066), an interleukin-23 (IL-23) inhibitor, received the Orphan Drug Designation status from the U.S. Food and Drug Administration (FDA) for the treatment of Crohn's disease in patients who are younger than 18 years.
ABBV-066 targets the cytokines of interleukin IL-23, known as a key role player in inflammatory and immune responses, will also be assessed in other autoimmune diseases – which are psoriasis, psoriatic arthritis and asthma.
On April 1 AbbVie obtained all rights to risankizumab from Boehringer Ingelheim, the pharmaceutical company that developed the interleukin-23 (IL-23) inhibitor.
Usually the status of "orphan drug" is assigned to medication that is potentially useful to treat a rare disease that affects a low percentage of the population.
Pharmaceutical companies are encouraged to assess the medication in clinical trials. After approval of their orphan drug by the FDA, companies receive some incentives. These consist of tax reductions and the exclusive rights to put the product on the market up to seven years after its first commercialization.
Crohn's disease is an inflammatory bowel disease that causes inflammation of the lining of the digestive tract until involving different areas. This disease can lead to abdominal pain, severe diarrhea, even malnutrition.
The inflammation caused by Crohn's disease often spreads deep into the layers of intestinal tissue affected and can be painful and debilitating. Life-threatening complications of the syndrome are not excluded.
The therapies can greatly reduce the signs and symptoms of Crohn's disease and even lead to long-term remission. Unfortunately, there is no known cure for Crohn's disease.
AbbVie closed Thursday at $59.16, down $1.70 (or -2.79%), with a volume of 6.97 million shares traded on the New York Stock Exchange. The stock lost 0.14% and was outperformed with 7.34% by the Standard & Poor's 500 year to date.
Disclosure: I have no positions in AbbVie.
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