AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderately to Severely Active colitis
today announced that it’s submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active colitis to the U.S. Food and Drug Administration (FDA), and to the ecu Medicines Agency (EMA) for the treatment of adults with moderately to severely active colitis , who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.
“Many people still struggle with symptoms related to their colitis , like fatigue, bowel urgency, bloody diarrhea and abdominal pain,” said Tom Hudson, senior vice chairman of research and development, chief scientific officer, AbbVie. “Upadacitinib has the potential to be a crucial new treatment option for people with colitis , who want to deal with these challenging and disruptive symptoms. we glance forward to working with regulatory authorities and hope to bring upadacitinib to people with colitis as quickly as possible.”
The applications are supported by data from two Phase 3 induction studies and one maintenance study.1-3 In these studies, significantly more patients treated with upadacitinib achieved the first endpoint of clinical remission (per Adapted Mayo Score) and every one secondary endpoints compared to placebo with 45 mg once daily at week 8 for the induction studies, and with 15 mg and 30 mg once daily at 52 weeks for the upkeep study.1-3
The safety results of upadacitinib, including the 45 mg dose as induction therapy, in these studies were generally according to the known safety profile of upadacitinib, with no new important safety risks observed.1-7
Ulcerative colitis may be a chronic, idiopathic, immune-mediated inflammatory bowel disease (IBD) of the massive intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.15,16 The hallmark signs and symptoms of colitis include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence.15,17 The disease course of colitis varies between patients and may range from quiescent disease to chronic refractory disease, which in some cases can cause surgery or complications, including cancer or death.16,19 The severity of symptoms and unpredictability of disease course can cause substantial burden and sometimes disability among those living with the disease.18
About the U-ACHIEVE Induction, U-ACCOMPLISH and U-ACHIEVE Maintenance Studies1-3,14-16
The three Phase 3 studies are multicenter, randomized, double-blind, placebo-controlled studies to guage the efficacy and safety of upadacitinib 45 mg once daily as induction therapy, and upadacitinib 15 mg and 30 mg once daily as maintenance therapy in subjects with moderate to severe colitis . Topline results of the U-ACHIEVE induction study were announced in December 2020, topline results of the second induction study, U-ACCOMPLISH, were announced in February 2021, and topline results of the U-ACHIEVE maintenance study were announced in June 2021. More information are often found on www.clinicaltrials.gov (NCT03006068, NCT03653026, NCT02819635).
About Upadacitinib (RINVOQ®)
Discovered and developed by AbbVie scientists, RINVOQ may be a selective and reversible JAK inhibitor that’s being studied in several immune-mediated inflammatory diseases.1-3,14-22 In human cellular assays, RINVOQ preferentially inhibits signaling by JAK1 or JAK1/3 with functional selectivity over cytokine receptors that signal via pairs of JAK2.30 RINVOQ 15 mg is approved within the U.S. for adults with moderately to severely active atrophic arthritis . RINVOQ 15 mg is also approved within the EU for adults with moderate to severe active atrophic arthritis , adults with active rheumatoid arthritis (PsA), adults with active Marie-Strumpell disease (AS), and adults and adolescents 12 years and older with moderate to severe atopic eczema (AD). RINVOQ 30 mg is approved within the EU for adults with moderate to severe AD under age 65. Phase 3 trials of RINVOQ in atrophic arthritis , atopic eczema , rheumatoid arthritis , axial spondylarthritis, regional enteritis , colitis , giant cell arteritis and Takayasu arteritis are ongoing.21-29 Use of RINVOQ in colitis isn’t approved and its safety and efficacy haven’t been evaluated by regulatory authorities.
Important Safety Information about RINVOQ (upadacitinib) within the us
RINVOQ U.S. Use and Important Safety Information
RINVOQ may be a prescription drug wont to treat adults with moderate to severe atrophic arthritis in whom methotrexate didn’t work well or couldn’t be tolerated. it’s not known if RINVOQ is safe and effective in children under 18 years aged .
What is the foremost important information I should realize RINVOQ?
RINVOQ may be a medicine which will lower the power of your system to fight infections. you ought to not start taking RINVOQ if you’ve got any quite infection unless your healthcare provider (HCP) tells you it’s okay.
Serious infections have happened in some people taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses which will spread throughout the body. Some people have died from these infections. Your HCP should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. you’ll be at higher risk of developing shingles (herpes zoster).
Lymphoma and other cancers, including skin cancers, can happen in people taking RINVOQ.
Blood clots within the veins of the legs or lungs and arteries are possible in some people taking RINVOQ. this might be life-threatening and cause death.
Tears within the stomach or intestines and changes in certain laboratory tests can happen. Your HCP should do blood tests before you begin taking RINVOQ and while you’re taking it. Your HCP may stop your RINVOQ treatment for a period of your time if needed due to changes in these biopsy results.