AbbVie’s Risankizumab for Crohn’s disease receives positive opinion from UK MHRA
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AbbVie’s Risankizumab for Crohn’s disease receives positive opinion from UK MHRA
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AbbVie’s Risankizumab for Crohn’s disease receives positive opinion from UK MHRA.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive opinion supporting the inclusion of AbbVie’s Risankizumab in the Early Access Medicines Scheme (EAMS).
The MHRA stipulates that certain Crohn’s disease (CD) patient groups will be able to receive Risankizumab in the future, while the drug’s marketing authorization application in the UK will continue to be reviewed.
Currently, patients eligible to receive Risankizumab include Crohn’s disease patients aged 16-17 years, and those who have not responded well to vedolizumab and ustekinumab, or who are not candidates for treatment with these drugs.
It is understood that Crohn’s disease places a significant burden on the UK healthcare system, with reports showing that there are more than 120,000 Crohn’s disease-related hospitalisations in the UK. For Britons living with Crohn’s disease, being able to access Risankizumab treatment through the Early Access programme, which aims to give patients early access to the drug before marketing authorisation, is a big step forward.
The monoclonal antibody Risankizumab can target IL-23A, selectively bind to the p19 subunit of IL-23 and inhibit the interaction of IL-23 with its receptor, thereby blocking IL-23 stimulation of Th17 cell subsets to induce IL production Cytokines such as -17A and IL-17F inhibit the occurrence of inflammation.
The drug was first approved in April 2019 and has now been approved by the US FDA and European EMA for the treatment of psoriatic arthritis and plaque psoriasis.
In a previous phase 2 trial, after 12 weeks of treatment, 24% and 37% of patients treated with Risankizumab at 200 mg and 600 mg experienced clinical remission (no symptoms or very mild symptoms) compared to 15% in the placebo group .
In addition, 15% and 20% of patients in the 200mg and 600mg dose groups achieved endoscopic remission, respectively, compared with 3% in the placebo group.
In addition, the Phase III, randomized, double-blind, placebo-controlled trials of ADVANCE and MOTIVATE evaluated the efficacy and safety of two 600mg and 1200mg doses of Risankizumab in adults with moderate to severe Crohn’s disease. In both trials, Risankizumab met the primary endpoints of clinical remission and endoscopic response at Week 12.
Results from another FORTIFY trial showed that compared with patients who discontinued Risankizumab, the proportion of patients who received Risankizumab at a dose of 360 mg also achieved a significant increase in endoscopic response and clinical remission within one year (52 weeks).
It is estimated that more than 217,000 people aged 16 and over in the UK have Crohn’s disease, with 40% of them having moderate or severe disease.
Often associated with inflammation and mucosal ulcers, Crohn’s disease causes pain, physical symptoms and complications that can have a significant impact on people’s daily activities, and mental health problems including depression and anxiety. According to Global Data, the Crohn’s disease drug treatment market will reach $13.4 billion by 2026.
Reference source:
AbbVie’s Crohn’s disease drug given green light by MHRA
AbbVie’s Risankizumab for Crohn’s disease receives positive opinion from UK MHRA
(source:internet, reference only)
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