Film-coated tablets for the treatment of intermediate or high-risk myelofibrosis in adults with moderate to severe anaemia

About the medicinal product

Omjjara contains the active substance momelotinib.

The medicinal product Omjjara is used for the treatment of intermediate- or high-risk myelofibrosis in adults with moderate to severe anaemia. The patients should have received prior treatment with a medicine containing the active substance ruxolitinib, or are not eligible for this treatment, and are not scheduled for stem cell transplantation.

Myelofibrosis is a rare form of leukaemia. In this disease, bone marrow is replaced by scar tissue, which disrupts the production of healthy blood cells. This can lead to anaemia, an enlarged spleen and other symptoms such as fever, night sweats, bone pain and itching.

Myelofibrosis exists in the following forms:

• Primary myelofibrosis: This form occurs in people who do not have a history of bone marrow disorder.
• Secondary myelofibrosis: This form develops in people with other types of leukaemia that caused their body to produce too many red blood cells (myelofibrosis after polycythaemia vera) or too many platelets (myelofibrosis after essential thrombocythaemia).

Omjjara is used in order to counteract the anaemia associated with the disease.

Since myelofibrosis is a rare and life-threatening disease, Omjjara has been authorised as an orphan drug. The term "orphan drug" is used to refer to important medicines for rare diseases.

Mode of action

Omjjara contains the active substance momelotinib, a so-called Janus kinase inhibitor. Janus kinase inhibitors block certain enzymes (Janus kinases) in the body.

The signalling pathway of Janus kinases, which play a role in the formation of blood cells, is hyperactive in myelofibrosis. Momelotinib works by specifically blocking Janus kinases 1 and 2. It also inhibits what is known as the activin A receptor type 1, thereby increasing the availability of iron in the body.

Thanks to this mechanism of action, momelotinib is able to increase the number of red blood cells, thereby counteracting the anaemia.

Use

Omjjara is a prescription-only medicine.

The medicinal product Omjjara is available as film-coated tablets in dosage strengths of 100 mg, 150 mg and 200 mg. The recommended dose is 200 mg once daily.

Omjjara may be taken with or without food.

Before starting treatment of the patients with Omjjara as well as during treatment, the doctor will perform regular blood tests and liver function tests to monitor the progress of treatment and detect possible side effects in good time.

Efficacy

The efficacy of Omjjara was investigated in the MOMENTUM study. This study investigated 195 patients with symptomatic and anaemic myelofibrosis who had previously been treated with a drug containing the active substance ruxolitinib. The study participants received either 200 mg Omjjara once daily or a drug containing the active substance danazol 300 mg twice daily.

The results of the study after 24 weeks showed that a higher percentage of patients – 25% in the Omjjara group compared to 9% in the danazol group – achieved an improvement in their symptoms. In addition, a numerically higher percentage of patients – 30% in the Omjjara group compared to 20% in the danazol group – did not require a blood transfusion.

Precautions, undesirable effects & risks

Omjjara must not be used in those who are hypersensitive to the active substance or any of the excipients.

The most common undesirable effects are infections (55.4%), haemorrhages (29%), diarrhoea (26.8%), low platelet count (25%), nausea (19.4%), fatigue (17.5%), cough (17.4%), dizziness (15.4%), peripheral nerve damage (14.6%), abdominal pain (14.1%), headache (13.9%), and a feeling of weakness (13.2%).

All precautions, risks, and other possible undesirable effects are listed in the Information for patients (package leaflet) and the Information for healthcare professionals.

Why the medicinal product has been authorised

No effective drug treatments are currently available for patients with myelofibrosis and anaemia who frequently suffer from a reduced quality of life and are reliant on regular blood transfusions. Consequently, the medical need for effective and safe medicines is high.

The medicinal product Omjjara offers a new treatment option. The pivotal study showed that Omjjara can reduce the symptoms associated with the disease of myelofibrosis and the dependence on transfusions. The benefit of Omjjara outweighs the risks.

Based on these findings, Swissmedic has authorised the medicinal product Omjjara, containing the active substance momelotinib, in Switzerland for the treatment of intermediate or high-risk myelofibrosis in adults with moderate to severe anaemia.

Further information on the medicinal product

Information for healthcare professionals:

Information for patients (package leaflet):

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.}