MHRA Grants Positive Opinion for AbbVie’s Risankizumab in Crohn’s Disease Under EAMS

Compiled by Fan Dongdong

Recently, the UK Medicines and Healthcare products Regulatory Agency (MHRA) issued a positive opinion, supporting the inclusion of AbbVie's risankizumab in the Early Access to Medicines Scheme (EAMS).

MHRA Specifies That Certain Crohn's Disease (CD) Patient Groups Will Be Eligible for Risankizumab Treatment in the Future, While Continuing to Review the Drug's Marketing Authorization Application in the UK. Currently, Patients Eligible for Risankizumab Treatment Include 16-17-Year-Old Crohn's Disease Patients, as Well as Those Who Have Had an Inadequate Response to Vedolizumab and Ustekinumab or Are Unsuitable for Treatment with These Drugs.

It is reported that Crohn's disease has brought a heavy burden to the UK healthcare system, with relevant reports showing that there are over 120,000 hospitalization cases related to Crohn's disease in the UK. For British patients suffering from Crohn’s disease, being able to access risankizumab treatment through the early access program marks significant progress. The purpose of this program is to allow patients to receive the drug at an early stage before it obtains marketing authorization.

The monoclonal antibody risankizumab can target IL-23A, selectively bind to the p19 subunit of IL-23, and inhibit the interaction between IL-23 and its receptor, thereby blocking IL-23 from stimulating the Th17 cell subset to induce the production of cytokines such as IL-17A and IL-17F, and suppressing 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 the previous Phase II trial, after 12 weeks of treatment, 24% and 37% of patients receiving 200mg and 600mg doses of risankizumab achieved clinical remission (no symptoms or very mild symptoms), compared to 15% in the placebo group. Additionally, 15% and 20% of patients in the 200mg and 600mg dose groups, respectively, reached endoscopic remission, versus only 3% in the placebo group.

In addition, the ADVANCE and MOTIVATE Phase III, randomized, double-blind, placebo-controlled trials also evaluated the efficacy and safety of two doses (600mg and 1200mg) of risankizumab in adults with moderate to severe Crohn's disease. In both trials, risankizumab met the primary endpoints of clinical remission at week 12 and endoscopic response. Results from another trial, FORTIFY, showed that compared to patients who discontinued risankizumab, those receiving a 360mg dose of risankizumab had a significantly higher proportion achieving endoscopic response and clinical remission over one year (52 weeks).

It is estimated that more than 217,000 people aged 16 and over in the UK suffer from Crohn's disease, with 40% experiencing moderate to severe symptoms. Crohn's disease is often associated with inflammation and mucosal ulcers, and the pain, physical symptoms, and complications it causes can significantly impact daily activities, leading to mental health issues such as depression and anxiety. According to Global Data, the market for Crohn's disease drug treatments is projected to reach $13.4 billion by 2026.

Reference Source: AbbVie’s Crohn’s disease drug given green light by MHRA