GSK's Omjjara approved in Japan for myelofibrosis, offering new treatment for this rare blood cancer.
GSK plc (LSE/NYSE: GSK) announced today that
Japan's Ministry of Health, Labour and Welfare (MHLW) has granted approval for
Omjjara (momelotinib) to treat myelofibrosis. Omjjara, an oral inhibitor
targeting JAK1/JAK2 and activin A receptor type 1 (ACVR1), is taken once daily.
The approval is supported by data from the pivotal phase III MOMENTUM and
SIMPLIFY-1 trials.This marks the fourth significant regulatory approval for
GSK's momelotinib in myelofibrosis treatment. Previously, it received approval
as Ojjaara from the US Food and Drug Administration, and as Omjjara from the
European Commission and the UK's Medicines and Healthcare products Regulatory
Agency.
“Myelofibrosis has a heavy disease burden,
with symptomatic patients experiencing spleen enlargement, fatigue, night
sweats and bone pain, along with anaemia which can lead to treatment
discontinuation and dependence on regular blood transfusions. With the approval
of Omjjara, myelofibrosis patients in Japan will have a new treatment option
for this complex blood cancer,” said Nina Mojas, Senior Vice President,
Oncology Global Product Strategy, GSK. Myelofibrosis is a rare form of blood
cancer affecting approximately 1 in 500,000 people globally, with an estimated
5,000 patients impacted in Japan. In Japan, around 70% of patients diagnosed
with primary myelofibrosis and about half of those with secondary myelofibrosis
experience moderate to severe anaemia at diagnosis.
Almost all patients are expected to develop
anaemia as the disease progresses. Those with myelofibrosis-related anaemia
require additional supportive treatments such as transfusions. More than 30% of
patients discontinue existing therapies due to anaemia. Individuals who are
anaemic and dependent on transfusions face a challenging prognosis with reduced
survival rates.
The approval was granted based on findings
from the pivotal phase III trials MOMENTUM and SIMPLIFY-1. MOMENTUM assessed
momelotinib's safety and effectiveness compared to danazol in treating and
reducing significant symptoms of myelofibrosis in a population experienced with
JAK inhibitors and experiencing anaemia. SIMPLIFY-1 evaluated how effective and
safe momelotinib is compared to ruxolitinib in myelofibrosis patients who had
not previously received JAK inhibitor therapy.