GSK plc ( GSK Quick Quote GSK - Free Report) announced that the FDA has granted approval to momelotinib to treat myelofibrosis patients with anemia.
Momelotinib is a novel, investigational JAK1/JAK2 inhibitor, which was added to GSK’s portfolio, following the acquisition of Sierra Oncology in 2022.
The drug, to be marketed by the trade name of Ojjaara, is now approved to treat intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythaemia) in adults with anemia. It became the first and the only drug approved to treat both newly diagnosed and previously treated myelofibrosis patients with anemia in the United States.
GSK’s stock has risen 6.5% so far this year against a decline of 14% for the
industry. Image Source: Zacks Investment Research
The NDA application for momelotinib was based on data from key phase III studies, including the pivotal MOMENTUM study. The MOMENTUM study evaluated momelotinib versus another anemia drug danazol for treating anemic myelofibrosis patients previously treated with an approved JAK inhibitor. In the MOMENTUM study, momelotinib achieved statistical significance in the primary and all pre-specified secondary endpoints, reporting a statistically significant benefit on symptoms, anemia and splenic size.
Myelofibrosis is a rare and fatal cancer of the bone marrow, which often leads to anemia that causes fatigue, increased risk of infection and bleeding or bruising due to reduced platelet count in patients. Almost all patients with myelofibrosis develop anemia over the course of the disease, with around 30% discontinuing treatment due to anemia. They then require blood transfusions for their treatment. This creates a significant unmet need for medicines like Ojjaara, which has the potential to become a standard-of-care treatment for myelofibrosis patients with anemia, claims GSK
We remind investors that in June, the FDA had delayed its decision on momelotinib’s new drug application by three months. A marketing authorization application by GSK is simultaneously being reviewed by the European Medicine Agency for approval in the EU.
GSK currently has a Zacks Rank #3 (Hold). You can see
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