The FDA has extended the review period for GSK’s Sierra Oncology myelofibrosis drug, momelotinib, through September 2023.
GSK, a leading UK-based pharmaceutical company, recently announced that the US Food and Drug Administration (FDA) has decided to extend the duration of its New Drug Application (NDA) evaluation for momelotinib, a drug developed for the treatment of a rare form of bone cancer. This extension adds an additional three months to the review process.
Per the updated action date of September 16, 2023, as stated in the new Prescription Drug User Fee Act (PDUFA), the FDA will make its decision on approval. The announcement, however, did not reveal the reason behind the extension of this review.
In the month of July 2022, GSK successfully achieved the treatment through its landmark $1.9 billion purchase of Sierra Oncology. The specific therapy in question is known as momelotinib, and it works as an inhibitor of Janus kinase (JAK) 1/2 as well as activin receptor type 1 (ACVR1).
Its main purpose is to treat the medical condition known as myelofibrosis. The mode of action of this treatment involves the stimulation of hepcidin transcription, resulting in a decrease in the likelihood of anemia.
In order to perform a comprehensive evaluation, the FDA will consider findings derived from the Phase III MOMENTUM study (NCT04173494). This specific double-blind study sought to examine the effectiveness of momelotinib compared to danazol in patients suffering from myelofibrosis. These patients were not only symptomatic and anemic, but had also received prior treatment with an FDA-approved JAK inhibitor.
In reviewing the study data, it was noted that the momelotinib-administered group had a positive safety record. Furthermore, the drug led to substantial improvements in symptoms associated with myelofibrosis, including symptoms of anemia, compared to the danazol-treated group.
The initial approach to treating myelofibrosis is to administer Jakafi (ruxolitinib) in conjunction with additional medications, including danazol. The FDA granted approval to Jakafi, developed by Novartis and Incyte Corp, in November 2011, making it the pioneering drug in the treatment of myelofibrosis. Danazol, an estrogen antagonist, relieves specific symptoms associated with the disease and improves spleen function.
In addition to its current applications, GSK is actively working on the development of Momelotinib for a number of other medical conditions. These conditions include non-small cell lung cancer, polycythemia vera, and pancreatic ductal adenocarcinoma. However, it is important to note that, to date, the drug has not received approval for use in any markets worldwide.
