Omvoh
Authorised
This medicine is authorised for use in the European Union
mirikizumab
MedicineHumanAuthorised
Overview
Omvoh is a medicine used to treat adults with ulcerative colitis (a disease causing inflammation of the large intestine with resulting ulceration and bleeding). Omvoh is used to treat moderately to severely active disease when conventional therapy or biological treatments do not work well enough, have stopped working, or cause unacceptable side effects.
Omvoh contains the active substance mirikizumab.
Omvoh can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating ulcerative colitis.
Omvoh is given as an infusion (drip) into a vein and as an injection under the skin. Treatment starts with an infusion into a vein lasting at least 30 minutes, given 3 times over 8 weeks. Another 3 infusions may be given every 4 weeks if the doctor considers that Omvoh is not working well enough.
Once the patient has completed treatment with infusions, they begin long-term maintenance treatment which is given as two separate injections under the skin, 4 weeks after the last infusion and then every 4 weeks thereafter.
After being trained, patients may inject Omvoh themselves if the doctor or nurse considers it appropriate. For more information about using Omvoh, see the package leaflet or contact your doctor or pharmacist.
The active substance in Omvoh, mirikizumab, is an antibody (a type of protein) designed to attach to interleukin-23 (IL-23) and block its activity. IL-23 is a protein that controls the growth and maturation of some types of T cells. These T cells, which are part of the immune system (the body's natural defences), are involved in causing inflammation that is linked to the development of ulcerative colitis. By blocking the action of IL-23, Omvoh reduces inflammation and symptoms associated with the disease.
Two main studies looked at how effective Omvoh was at treating moderately to severely active ulcerative colitis when other treatments did not work well enough or caused unacceptable side effects.
In the first study involving 1,162 patients, 24% (210 out of 868) of those who received the recommended dose of Omvoh infusions over 8 weeks had clinical remission (a decrease in or disappearance of signs and symptoms of the disease) after 12 weeks compared with 13% (39 out of 294) of patients who received placebo (a dummy treatment). Clinical remission was evaluated by the modified Mayo score (MMS), which measures changes in stool frequency, rectal (last several inches of the large intestine closest to the anus) bleeding and endoscopic subscore (measure of inflammation in the intestines based on a procedure that uses a tube with a camera to look inside the body).
A second study of 544 patients from the first main study who responded to Omvoh looked at the effectiveness of maintenance treatment at a lower dose given every 4 weeks by injection under the skin. After 40 weeks, around 50% (182 out of 365) of patients receiving Omvoh were in clinical remission, as evaluated by the MMS score, compared with 25% (45 out of 179) who received placebo.
For the full list of side effects and restrictions with Omvoh, see the package leaflet.
The most common side effects with Omvoh (which may affect up to 1 in 10 people) include upper respiratory tract infections (nose and throat infections), headache, rash and reactions at the site of injection (when given by injection under the skin).
Omvoh must not be used in patients with active serious infections such as tuberculosis.
Omvoh has been shown to provide benefits in adult patients with moderately to severely active ulcerative colitis for whom conventional or biological treatments did not work or are not tolerated; in around half of patients who responded to treatment the positive effects were maintained with continued use. The side effects of Omvoh are considered manageable, with the most important side effect being infection. Information regarding long term use of Omvoh is limited and studies are ongoing to evaluate this.
The European Medicines Agency therefore decided that Omvoh’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Omvoh have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Omvoh are continuously monitored. Suspected side effects reported with Omvoh are carefully evaluated and any necessary action taken to protect patients.
Omvoh received a marketing authorisation valid throughout the EU on 26 May 2023.
Product information
Latest procedure affecting product information: IB/0003
22/12/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Omvoh
- Active substance
- Mirikizumab
- International non-proprietary name (INN) or common name
- mirikizumab
- Therapeutic area (MeSH)
- Colitis, Ulcerative
- Anatomical therapeutic chemical (ATC) code
- L04AC
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Omvoh is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
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