Crohn’s disease can be treated with drugs that control inflammation and reduce the frequency of bowel disease flares. These treatments include biological drugs that target certain immune system proteins. However, these therapies are insufficient for some patients. FDA has officially recognized A currently available AbbVie drug to treat Crohn’s disease marks a new first in the treatment of the disease.
Regulators approved risankizumab, a drug already marketed under the name “Skyrizi” by North Chicago, Illinois-based AbbVie, for approved uses in plaque psoriasis and psoriatic arthritis. Skyrizi is an antibody designed to bind to interleukin 23 (IL-23). This cytokine, or cell signaling protein, is involved in one way inflammation develops in the body. By binding to it and blocking it, Skyrizi prevents IL-23 from triggering pro-inflammatory activity. Additional drug approvals announced Friday include the use of Skyrizi in adults with moderately to severely active Crohn’s disease. This is the first drug targeting IL-23 approved for this indication.
Skyrizi’s latest approval is based on results from two pivotal studies comparing AbbVie’s drug to a placebo. The drug was administered as a one-hour infusion of 600 mg at the start of the study, followed by a single 360 mg dose via a prefilled syringe at week 12 and every 8 weeks thereafter. The primary study goals were to show a reduction in signs of disease observed by endoscopy and to assess clinical remission, the reduction in disease symptoms to the point of almost disappearing.
AbbVie reported that patients in the Skyrizi group achieved both study goals compared with patients taking a placebo. In a 52-week maintenance study, AbbVie reported that significantly more patients achieved these two primary goals compared to the placebo group.Results from two pivotal Phase 3 trials of Crohn’s drug are post May in The Lancet.
“In both induction and maintenance clinical trials, significantly more adult patients had few or no symptoms compared to placebo, with significantly less visible signs of intestinal inflammation,” said Marla Dubinsky, director of the Division of Pediatric Gastroenterology at Mount Sinai Health System and co-directors of the Susan and Leonard Feinstein Center for IBD, said in a prepared statement. “This approval provides healthcare professionals with a much-needed additional option for treating the devastating symptoms of Crohn’s disease.”
Dubinsky is a paid consultant and consultant for AbbVie.
The most common side effects reported in the Crohn’s disease study included fever, headache, and anemia. This drug does carry more serious risks. Like other drugs that suppress the immune system, Skyrizi can increase the risk of infection. Upper respiratory tract infection is listed as one of the more common side effects of the drug. Additionally, in the Crohn’s disease study, one participant who received two doses of Skyrizi developed drug-induced liver injury and a rash that required hospitalization. The drug’s label reminds clinicians to monitor for signs of liver problems for at least 12 weeks of treatment.
Sales of the drug have grown steadily since Skyrizi was first approved in 2019 to treat moderate-to-severe plaque psoriasis. Skyrizi’s global sales were $2.9 billion last year, up nearly 85 percent from the previous year.Earlier this year, the FDA approved Skyrizi as a Treating Active Psoriatic Arthritisthe second approved indication for this product.
AbbVie is developing other treatments for Crohn’s disease. Rinvoq is a small molecule JAK inhibitor in late-stage development for this disease. AbbVie in February report The drug met the primary goal of the second of two phase 3 studies in moderate-to-severe Crohn’s disease.
Rhythm Pharmaceuticals’ obesity drug wins FDA approval again
Among other complementary drug approvals in development, Rhythm Pharmaceuticals received good and bad news about its weight management drug Imcivree.The U.S. Food and Drug Administration granted Friday Additional approval this drug as treatment Bardet-Biedl Syndrome (BBS), a rare genetic disorder that causes insatiable hunger, which in turn leads to severe obesity. However, the agency rejected the biotech’s application to expand the drug’s approval to another disease.
Imcivree is a peptide designed to target the melanocortin 4 receptor (MC4R), a protein in the brain that is key to pathways that regulate hunger and energy expenditure, which in turn affects body weight.The medicine is Approved for the first time In 2020, for weight management in three rare genetic diseases that contribute to obesity: pro-opioid melanocortin deficiency, proprotein subtilisin/kexin type 1 deficiency, and leptin receptor deficiency.
In BBS, Imcivree is designed to restore function of the MC4R pathway to reduce hunger and body weight. Phase 3 results from BBS showed that the drug met clinical trial goals for weight loss and hunger reduction. In patients 6 years and older with obesity caused by BBS, the Rhythm drug resulted in an average 7.9% reduction in body mass index without diet or exercise. In contrast, the placebo group had a mean BMI reduction of 4.5%. In patients 12 years of age and older, Rhythm also reported statistically significant changes in scores based on the scale used to assess hunger.
The ultra-rare nature of Imcivree’s approved indication means the drug isn’t yet a big seller. Rhythm reported revenue of $3.1 million for the drug in 2021. But Imcivree stands for “the plumbing in the product.” The company is in a mid-stage clinical trial testing the drug in 10 other genes associated with the MC4R pathway. However, Rhythm missed an opportunity to add another rare disease to Imcivree’s approved list. The FDA rejection announced Friday was for Alström syndrome, another genetic disorder that can lead to hunger and obesity. Rhythm said it plans to review Imcivree’s potential path forward in this indication.
Photo by AbbVie
