# GSK momelotinib receives US FDA acceptance for New Drug Application

- Link: https://www.directorstalkinterviews.com/gsk-momelotinib-receives-us-fda-acceptance-for-new-drug-application/4121077955
- Published: 2022-08-17T07:33:30+01:00
- Author: Amilia Stone

**[GSK plc](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l)**(
[LON:GSK](https://www.directorstalkinterviews.com/ftse-company/glaxosmithkline-plc/gsk.l))
has announced that the US Food and Drug Administration (FDA) accepted the New Drug
Application (NDA) for momelotinib, a potential new medicine with a proposed differentiated
mechanism of action that may address the significant unmet medical needs of myelofibrosis
patients with anaemia. The US FDA has assigned a Prescription Drug User Fee Act 
action date of 16 June 2023.

The NDA is based on the results from key phase III trials, including the pivotal
MOMENTUM trial, which met all primary and key secondary endpoints, including Total
Symptom Score (TSS), Transfusion Independence (TI) rate and Splenic Response Rate(
SRR). The primary analysis data from the MOMENTUM trial were recently presented 
at the 2022 American Society of Clinical Oncology Annual Meeting and the European
Hematology Association 2022 Hybrid Congress.

Momelotinib is not currently approved in any market.

**About the pivotal MOMENTUM phase III clinical trial**

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. The trial was designed
to evaluate the safety and efficacy of momelotinib for treating and reducing key
hallmarks of the disease: symptoms, blood transfusions (due to anaemia) and splenomegaly(
enlarged spleen).

The trial’s primary efficacy endpoint was TSS reduction of ≥50% over the 28 days
immediately before the end of Week 24 compared to baseline TSS, using the Myelofibrosis
Symptom Assessment Form. Key secondary endpoints included TI rate for ≥12 weeks 
immediately before the end of Week 24 with haemoglobin levels ≥ 8 g/dL and SRR based
on splenic volume reduction of ≥35% at Week 24 from baseline.

Patients were randomised at 2:1 to receive either momelotinib or danazol (n=130 
and n=65, respectively). After 24 weeks of treatment, patients on danazol were allowed
to crossover to receive momelotinib. Early crossover to momelotinib was available
for confirmed splenic progression. The trial enrolled 195 patients across 21 countries.

**About momelotinib**

Momelotinib is a potential new medicine with a differentiated mechanism of action,
with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 
1, and JAK2 and activin A receptor, type I (ACVR1).^([i])^(,[ii],[iii],[iv]) Inhibition
of JAK1 and JAK2 may improve constitutional symptoms and splenomegaly.^(i)^(,)^(
ii)^(,)^(iv) Additionally, direct inhibition of ACVR1 leads to a decrease in circulating
hepcidin, which is elevated in myelofibrosis and contributes to anaemia.^(i)^(,)
^(ii)^(,)^(iii)^(,)^(iv)

Momelotinib was most recently developed by Sierra Oncology, Inc., which GSK plc 
acquired in July 2022, building on GSK’s expertise in haematology and portfolio 
of specialty medicines and vaccines.

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