Concentrate for solution for injection for the treatment of adults with moderate to severe Crohn’s disease

About the medicinal product

The medicinal product Omvoh contains the active substance mirikizumab and is used for the treatment of adult patients with moderate to severe Crohn’s disease who have responded inadequately to, who no longer respond to, or who do not tolerate conventional therapies or a biological treatment.

Crohn’s disease is a condition that causes inflammation in all parts of the digestive tract, but most frequently the intestines. The inflammation leads to thickening of the intestinal wall and narrowing of the intestinal lumen. Healthy segments of intestine alternate with affected segments. Typical symptoms of Crohn’s disease include abdominal pain, diarrhoea (with or without visible bleeding), fatigue, and weight loss. Symptoms are usually chronic and come and go, but the course of the disease may differ.

Omvoh was authorised by Swissmedic on 30 November 2023 for the treatment of adult patients with moderately to severely active ulcerative colitis who have responded inadequately, or who no longer respond, to conventional therapies or a biological treatment, or in whom conventional therapies or a biological treatment are contraindicated or were not tolerated.

The indication extension for Omvoh was authorised as part of the joint initiative of the Access Consortium. This joint initiative is a collaborative project between the drug regulatory authorities in Australia (Therapeutic Goods Administration, TGA), Canada (Health Canada, HC), Singapore (Health Sciences Authority, HSA), the United Kingdom (Medicines & Healthcare products Regulatory Agency, MHRA), and Swissmedic. The joint initiative coordinates the assessment of authorisation applications for new active substances that have been submitted in at least 2 of the 5 countries.

The application for indication extension for Omvoh was submitted under the joint initiative to the drug regulatory authorities in Australia and Switzerland. Each country assessed a part of the application and then shared and discussed the results. At the end of the process, each authority decided on the application independently.

The requirements for issuing a comprehensive SwissPAR (Swiss Public Assessment Report) and a Summary report on authorisation based on this SwissPAR have not been fulfilled. Swissmedic refers to the authorisation of the foreign reference authorities.

Further information on the medicinal product

Information for healthcare professionals:

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}