TOP NEWS: US FDA accepts GSK's new drug application for momelotinib

(Alliance News) - GSK PLC on Wednesday said the US Food & Drug Administration has accepted the new drug application for its momelotinib, which could potentially treat a rare blood cancer myelofibrosis.

Back in July, the biopharma firm bought Sierra Oncology Inc for USD1.9 billion. The acquisition included momelotinib, a late-stage potential treatment for myelofibrosis patients with anaemia.

In June, Sierra presented data for the treatment from phase III Momentum trial, which met all its key primary and secondary endpoints. The drug showed a statistically meaningful benefit on symptoms, splenic response, and anaemia.

GSK said that the new drug application is based on the results from the "pivotal" Momentum trial, which enrolled 195 patients across 21 countries.

"Momentum is a global, randomised, double-blind phase III clinical trial of momelotinib versus danazol in patients with myelofibrosis who were symptomatic and anaemic and had been previously treated with an FDA-approved JAK inhibitor," GSK explained.

Patients were randomised at a two to one ratio to receive either momelotinib or danazol.

The company said the trial's primary efficacy endpoint was total symptom score reduction of at least 50% over the 28 days immediately before the end of week 24 compared to baseline total symptom score.

Meanwhile, key secondary endpoints included transfusion independence rate for at least 12 weeks immediately before the end of week 24 with haemoglobin levels equal to or greater than 8 grams per decilitre and splenic response rate based on splenic volume reduction of at least 35% at week 24 from baseline, it added.

Momelotinib is currently not approved in any markets, GSK said.

GSK shares were down 1.4% to 1,406.60 pence each in London early Wednesday.

By Sophie Rose; sophierose@alliancenews.com

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