REG - GSK PLC - European Commission authorises Omjjara in the EU

GSKAnnouncement

29/01/2024 07:00

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RNS Number : 6076Z  GSK PLC  29 January 2024

Issued: 29 January 2024, London UK

 

European Commission authorises GSK's Omjjara (momelotinib)

 

·  Omjjara is the first medicine in the EU specifically indicated for
treating  splenomegaly (enlarged spleen) or symptoms in adult myelofibrosis
patients with moderate to severe anaemia

·  Authorisation may address high unmet need, with nearly all
myelofibrosis  patients estimated to develop anaemia over the course of the
disease((1 (#_edn1) ))(,(2 (#_edn2) )),(3 (#_edn3) ),(4 (#_edn4) )

·   Indicated in both newly diagnosed patients and those previously treated
with  existing standard of care

 

GSK plc (LSE/NYSE: GSK) today announced the European Commission* granted
marketing authorisation for Omjjara (momelotinib), a once-a-day, oral
JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. Omjjara is the
first authorised medicine in the EU for disease-related splenomegaly (enlarged
spleen) or symptoms in adult patients with moderate to severe anaemia who have
primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential
thrombocythaemia myelofibrosis and who are Janus kinase (JAK) inhibitor naïve
or have been treated with ruxolitinib.

 

Nina Mojas, Senior Vice President, Oncology Global Product Strategy, GSK,
said: "The challenges of living with myelofibrosis can be burdensome, and
symptomatic patients can experience spleen enlargement, fatigue, night sweats
and bone pain. Until now, there have been no options specifically indicated to
treat these symptoms in patients who also experience anaemia. The
authorisation of Omjjara brings a new treatment option with a differentiated
mechanism of action to these patients in the EU."

 

Myelofibrosis is estimated to affect 1 in 10,000 people in the EU.((5 (#_edn5)
))(,(6 (#_edn6) )) About 40% of patients have moderate to severe anaemia at
the time of diagnosis and nearly all patients are estimated to develop anaemia
over the course of the disease.(1,2)(,)(3)(,)(4) Myelofibrosis patients with
anaemia require additional supportive care, including transfusions, and more
than 30% will discontinue treatment due to anaemia.((7 (#_edn7) )) Patients
who are transfusion dependent have a poor prognosis and shortened survival.((8
(#_edn8) ))(,(9)),(10 (#_edn10) ),(11 (#_edn11) ),(12 (#_edn12) ),(13
(#_edn13) ),(14 (#_edn14) ),(15 (#_edn15) ),(16 (#_edn16) )

 

Francesca Palandri, MD, PhD, IRCCS S. Orsola-Malpighi, Bologna University
Hospital, Italy, said: "The EU authorisation of Omjjara represents a
meaningful advancement for eligible patients with myelofibrosis, and
particularly for those with moderate to severe anaemia who need new treatment
options that may reduce their disease-related burden. The availability of a
single therapy for key manifestations of myelofibrosis is a clear step forward
for eligible patients."

 

The authorisation of momelotinib is based on the MOMENTUM pivotal phase III
trial and a subpopulation of adult patients with moderate to severe anaemia
(haemoglobin <10 g/dL) from the SIMPLIFY-1 phase III trial.((17 (#_edn17)
))(,(18 (#_edn18) )) MOMENTUM was designed to evaluate the safety and efficacy
of momelotinib versus danazol for the treatment and reduction of key
manifestations of myelofibrosis in an anaemic, symptomatic, JAK
inhibitor-experienced population. SIMPLIFY-1 was designed to evaluate the
efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis
patients who had not received a prior JAK-inhibitor therapy.

 

In these clinical trials, the most common adverse reactions were diarrhoea,
thrombocytopaenia, nausea, headache, dizziness, fatigue, asthenia, abdominal
pain, and cough.(17,18)

 

About Omjjara (momelotinib)

Momelotinib has a differentiated mechanism of action, with inhibitory ability
along three key signalling pathways: Janus kinase (JAK) 1, JAK2, and activin A
receptor, type I (ACVR1).(8)(,)(17)(,19,20) Inhibition of JAK1 and JAK2 may
improve constitutional symptoms and splenomegaly.(8,17)(,)(20) Additionally,
inhibition of ACVR1 leads to a decrease in circulating hepcidin levels,
potentially contributing to anaemia-related benefit.(8,17)(,)(19)(,)(20)

 

In September 2023, the US Food and Drug Administration licensed
(https://www.gsk.com/en-gb/media/press-releases/ojjaara-momelotinib-approved-in-the-us-as-the-first-and-only-treatment-indicated-for-myelofibrosis-patients-with-anaemia/)
momelotinib under the brand name Ojjaara for the treatment of intermediate or
high-risk myelofibrosis, including primary myelofibrosis or secondary
myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia),
in adults with anaemia.

 

Important Information for Omjjara in the EU

 

Indication

Omjjara is indicated for the treatment of disease-related splenomegaly
(enlarged spleen) or symptoms in adult patients with moderate to severe
anaemia who have primary myelofibrosis, post polycythaemia vera myelofibrosis
or post essential thrombocythaemia myelofibrosis and who are Janus kinase
(JAK) inhibitor naïve or have been treated with ruxolitinib.

 

Refer to the Omjjara EMA Reference Information
(https://www.ema.europa.eu/en/medicines/human/EPAR/omjjara
(https://www.ema.europa.eu/en/medicines/human/EPAR/omjjara) ) for a full list
of adverse events and the complete important safety information in the EU.

 

About myelofibrosis

Myelofibrosis is a rare blood cancer that disrupts the body's normal
production of blood cells because of dysregulated JAK-signal transducer and
activator of transcription protein signalling. The clinical hallmarks of
myelofibrosis are splenomegaly (enlarged spleen), progressive anaemia and
debilitating constitutional symptoms, such as fatigue, night sweats and bone
pain, attributable to ineffective haematopoiesis and excessive production of
proinflammatory cytokines.((21 (#_edn21) ))

 

About the pivotal clinical trials

MOMENTUM was a phase III, global, multicentre, randomised, double-blind study
investigating momelotinib versus danazol in patients (n=195) with
myelofibrosis who were symptomatic and anaemic and had been previously treated
with a licensed JAK inhibitor. The trial was designed to evaluate the safety
and efficacy of momelotinib for treating and reducing key hallmarks of the
disease: symptoms, blood transfusions (due to anaemia), and splenomegaly. The
MOMENTUM trial met all its primary and key secondary endpoints, demonstrating
statistically significant response with respect to constitutional symptoms,
splenic reduction and transfusion independence in patients treated with
momelotinib versus danazol (Total Symptom Score reduction of 50% or greater:
25% momelotinib, 9% danazol, p = 0.0095; reduction of spleen volume by 35% or
greater: momelotinib 22%, danazol 3%, p = 0.0011; no transfusions and all
haemoglobin values ≥8 g/dL in the 12 weeks prior to week 24: momelotinib
30%, danazol 20%).(17) Results from the 24-week randomised treatment period
were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual
Meeting and subsequently published in The Lancet,((22 (#_edn22) ))(,(23
(#_edn23) )) with 48-week data presented at the 64th American Society of
Hematology (ASH) Annual Meeting and Exposition in December 2022 and
subsequently published in The Lancet.((24 (#_edn24) ))(,(25 (#_edn25) ))

 

SIMPLIFY-1 was a multicentre, randomised, double-blind, phase III study that
compared the safety and efficacy of momelotinib to ruxolitinib in patients
(n=432) with myelofibrosis who had not received prior treatment with a JAK
inhibitor. Safety and efficacy results for SIMPLIFY-1 were based upon a subset
of patients (n=181) with anaemia at baseline. The efficacy of momelotinib in
the treatment of patients with myelofibrosis in SIMPLIFY-1 was based on spleen
volume response (reduction of spleen volume by 35% or greater: 31%
momelotinib, 33% ruxolitinib p = 0.026).(18)

 

GSK in oncology

GSK is committed to maximising patient survival through transformational
medicines, with a current focus on breakthroughs in immuno-oncology and
tumour-cell targeting therapies, and development in haematologic malignancies,
gynaecologic cancers, and other solid tumours.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com.

 

* The European Commission has the authority to authorise medicines for
European Union member states, as well as in the European Economic Area (EEA)
countries Iceland, Norway and Liechtenstein, and Northern Ireland.

 

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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described under
Item 3.D "Risk factors" in the company's Annual Report on Form 20-F for 2022,
and Q3 Results for 2023.

 

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https://doi.org/10.3109/10428194.2013.813500

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 23  (#_ednref23) Verstovsek S, et al. Momelotinib versus danazol in
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