GSK’s Omjjara approved by MHRA to treat myelofibrosis patients with anaemia

2024-02-02

临床结果临床3期上市批准

GSK’s Omjjara approved by MHRA to treat myelofibrosis patients with anaemia

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来源: PMLiVE

GSK’s Omjjara (momelotinib) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adult myelofibrosis patients with moderate or severe anaemia.

Myelofibrosis is a rare blood cancer that affects one in every 500,000 people worldwide, 40% of whom have moderate-to-severe anaemia at the time of diagnosis.

Nearly all patients develop anaemia at some point during the course of their disease.

The agency’s decision was supported by results from the pivotal MOMENTUM phase 3 trial, which evaluated Omjjara in comparison to another anaemia treatment called danazol.

Approximately 195 patients with myelofibrosis and anaemia who had previously been treated with a Janus Kinase (JAK) inhibitor were given either 200mg of Omjjara once daily or 300mg of danazol twice daily for 24 weeks.

The treatment works to inhibit the action of enzymes known as JAKs (JAK1, JAK2), which control the activity of cytokines.

Cytokines are proteins involved in inflammation in the body, the production of different blood components and regulating the immune system.

Omjjara also inhibits the activin A receptor type 1 (ACVR1), which increases the production of hepcidin, a protein that traps iron in the liver and reduces absorption from food, leading to anaemia.

Myelofibrosis causes these proteins to act abnormally. The treatment works to block the overproduction of cytokines and hepcidin, reducing inflammation and increasing iron and haemoglobin levels in the blood.

The trial met all of its primary and key secondary endpoints, showing that Omjjara was more effective than danazol in reducing symptoms and spleen size.

Julian Beach, interim executive director, healthcare quality and access, MHRA said: “We’re assured that the appropriate regulatory standards for the approval of this medicine have been met.

“Keeping patients safe and enabling their access to high-quality, safe and effective medical products are key priorities for us.”

The MHRA has assured that it will continue to keep the safety and effectiveness of Omjjara under close review.

Omjjara has already received approval from the European Commission following a recommendation by the Committee for Medicinal Products for Human Use.

The treatment is the first medicine specifically authorised in the EU to treat splenomegaly (enlarged spleen) or symptoms in adult myelofibrosis patients with moderate-to-severe anaemia.

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