British pharmaceutical company GSK announced on Friday that the U.S. Food and Drug Administration (FDA) has approved its oral therapy for treating anemia in patients with myelofibrosis, a type of bone marrow cancer.
The FDA’s decision comes after a delay in July to review additional data regarding the therapy.
The newly approved therapy, named Ojjaara, also known as momelotinib, is indicated for use in patients with myelofibrosis, regardless of their prior treatment history, according to GSK’s statement.
While Ojjaara falls under the same class of treatments as other available options, it has the added benefit of reducing the levels of a protein called hepcidin, which plays a role in iron regulation within the body.
Myelofibrosis is associated with elevated levels of hepcidin, which disrupts the production of blood cells, often leading to severe anemia. People with myelofibrosis-related anemia typically rely on regular blood transfusions to improve their red blood cell count.
Government data indicates that myelofibrosis affects fewer than 50,000 patients in the United States.
The FDA’s approval is based on data from a late-stage study demonstrating that Ojjaara effectively reduces disease symptoms and lessens patients’ dependence on blood transfusions compared to an alternative anemia treatment called danazol.
Analyst Damien Conover from Morningstar estimates that Ojjaara could capture around 50% of the second-line myelofibrosis market and has projected peak annual sales of approximately £500 million ($627.45 million).
“Momelotinib drives long-term growth for GSK as its patent protection extends beyond 2033 in key markets,” explains Conover, indicating the therapy’s potential value for the company.
Last year, GSK bolstered its cancer portfolio by acquiring the rights to momelotinib through a $1.9 billion buyout of cancer drug developer Sierra Oncology.
GSK’s oncology business accounted for just 2% of its total sales in 2022 and experienced setbacks in clinical trials for two cancer compounds that were previously anticipated to be blockbusters.
Sierra Oncology had previously acquired momelotinib from Gilead Sciences in 2018 for an initial payment of $3 million, with the potential to receive up to $195 million in milestone payments.