FDA nod for Ojjaara, only treatment for myelofibrosis patients with anemia

Just three months ago, the US Food and Drug Administration (FDA) extended the review period of the new drug application (NDA) for blood cancer drug momelotinib by three months to provide time to review recently submitted data. GSK’s shares edged up 1.6% to £14.87.

Spot on time, late Friday UK pharma major GSK (LSE: GSK) announced that the drug had been approved, under the trade name Ojjaara, with a broader indication than had been expected. The drug is authorized for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia), in adults with anemia.

Ojjaara is a once-a-day, oral JAK1/JAK2 and activin A receptor type 1 (ACVR1) inhibitor. To date, it is the only approved medicine for both newly-diagnosed and previously-treated myelofibrosis patients with anemia that addresses the key manifestations of the disease, namely anemia, constitutional symptoms, and splenomegaly (enlarged spleen). The broad FDA nod somewhat levels the playing field for Ojjaara against Incyte’s  (Nasdaq: INCY) well-established Jakafi (ruxolitinib).