GSK Plc Announces The CHMP Of The EMA Has Adopted A Positive Opinion Recommending Approval Of Momelotinib For The Treatment Of Disease-related Splenomegaly Or Symptoms In Adult Patients With Moderate To Severe Anaemia
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GSK has received a positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia, according to an SEC filing. If approved, momelotinib would be the first EU treatment specifically for myelofibrosis patients with moderate to severe anaemia. The decision on EU marketing authorization is expected by early 2024.
November 13, 2023 | 2:13 pm
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GSK's momelotinib has received a favorable opinion from CHMP for treating myelofibrosis patients with anaemia. If approved, it will be the first such treatment in the EU, with a decision expected by early 2024.
The positive opinion from CHMP is a significant regulatory milestone for GSK, indicating a high likelihood of approval for momelotinib in the EU. This could potentially boost GSK's market position in the treatment of myelofibrosis with anaemia, a currently unmet medical need. The news is likely to be viewed positively by investors, potentially leading to a short-term increase in GSK's stock price.
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