OJJAARA™ (momelotinib)

FOR IMMEDIATE RELEASE:

OJJAARA™ (momelotinib) Now Available from Onco360 For the Treatment of Intermediate or High-Risk Myelofibrosis (MF), Including Primary MF or Secondary MF [Post-Polycythemia Vera (PV) and Post- Essential Thrombocythemia (ET)], in Adults with Anemia

Louisville, KY — September 22, 2023 — Onco360^®, the nation’s leading independent Specialty Pharmacy, has been selected as a pharmacy partner by GlaxoSmithKline for OJJAARA™ (momelotinib). OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis (MF), including primary MF or secondary MF [post-polycythemia vera (PV) and post-essential thrombocythemia (ET)], in adults with anemia.

“Onco360 is grateful for the opportunity to partner with the team at GlaxoSmithKline and become a specialty pharmacy provider for OJJAARA,” said Benito Fernandez, Chief Commercial Officer. “We are proud to add this unique treatment option for adult MF patients with anemia.”

Based on the National Comprehensive Cancer Network (NCCN) guidelines for myeloproliferative neoplasms, MF is included with PV and ET within a group of heterogenous disorders of the hematopoietic system known as Philadelphia chromosome-negative myeloproliferative neoplasms (MPN). The estimated prevalence of MF in the United States is 13,000 patients. The median age at time of original primary MF diagnosis is 67 years old. Dependent upon genetic mutation status (i.e. CALR-mutant, JAK2-mutant, MPL-mutant, triple-negative MF) underlying the patient’s MF, median overall survival ranges from 3 to 18 years.^1,2

The efficacy of OJJAARA in the treatment of adults with intermediate 1, intermediate 2, or high-risk MF, including primary MF, post-PV MF or post-ET MF, as defined by Dynamic International Prognostic Scoring System (DIPSS) or International Prognostic Scoring System (IPSS) for MF, was established in the MOMENTUM trial (NCT04173494) and in a subpopulation of adults with anemia in the SIMPLIFY-1 trial (NCT01969838). As part of the MOMENTUM trial, symptomatic and anemic MF patients treated with OJJAARA had a significantly improved incidence of Myelofibrosis Symptom Assessment Form (MFSAF) Version 4.0 Total Symptom Score Reduction of 50% or more (25% vs. 6%, p-value <0.01), a significantly improved incidence of transfusion independence (no transfusion or hemoglobin less than 8 g/dL between weeks 12 and 24; 30% vs. 20%, p-value 0.023), and a significantly improved incidence of spleen volume reduction by 25% or more (39% vs. 6%, p-value <0.0001) compared to symptomatic and anemic MF patients treated with Danazol.³

Please see the full Prescribing Information for OJJAARA™.

Media Contact:

Benito Fernandez, Chief Commercial Officer
[email protected]
516-640-1332

References:

1. NCCN Guidelines Myeloproliferative Neoplasms Version 3.2022. Accessed September 2023 https://jnccn.org/view/journals/jnccn/20/9/article-p1033.xml
2. UpToDate^® Clinical Manifestations and Diagnosis of Primary Myelofibrosis. Accessed September 2023. Clinical manifestations and diagnosis of primary myelofibrosis – UpToDate
3. OJJAARA Prescribing Information. Accessed September 2023.
   OJJAARA-PI-PIL.PDF (gskpro.com)

Trademarks:

GlaxoSmithKline, OJJAARA™ and associated logos are registered trademarks of the GSK group of companies.