(Sharecast News) – Phama giant GSK has announced that Japanese regulators are reviewing its proposed new momelotnib treatment for people with myelofibrosis – a type of blood cancer.
Momelotnib, which is currently not approved in any market, is hoped to address the significant medical needs of myelofibrosis patients, especially those with anaemia.
The new drug application (NDA), which included data from clinical trials addressing key clinical manifestations of myelofibrosis, has now been accepted for review by Japan’s Ministry of Health, Labour and Welfare.
Momelotnib is currently under review in the US. In June, the Food and Drug Administration said it was extending the. review period of the NDA by three months as it needed more time to review the data. The FDA should make a decision by 16 September.
In a statement on Monday, GSK explained: “About 70% of patients diagnosed with primary myelofibrosis and about half of patients diagnosed with secondary myelofibrosis in Japan 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.”
