ropeginterferon alfa-2b-njft recognized by National Comprehensive Cancer Network® (NCCN®) as recommended treatment option, listing it as a Category 1 preferred regimen for ET patients with inadequate response to or loss of response to existing treatments
BURLINGTON, Mass.–(BUSINESS WIRE)–PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced that the U.S. NCCN Clinical Practice Guidelines in Oncology have been updated to include ropeginterferon alfa-2b-njft as a Category 1 preferred treatment option for high-risk patients with essential thrombocythemia (ET) who have an inadequate response to or loss of response to existing therapies. The use of ropeginterferon alfa-2b-njft for ET is currently still investigational, but it is currently under review by FDA.
Category 1 recommendations reflect high-level evidence and uniform NCCN consensus that an intervention is appropriate.
“Inclusion of ropeginterferon alfa-2b-njft as a Category 1 preferred regimen in the NCCN Guidelines represents a significant milestone for patients with essential thrombocythemia and for the physicians who treat them,” said Ko-Chung Lin, Ph.D., Founder and Chief Executive Officer of PharmaEssentia. “This update recognizes the strength of the clinical evidence and reinforces its role as an important potential therapeutic option for high-risk patients with limited treatment alternatives. The FDA’s review of our supplemental Biologics License Application (sBLA) to expand the ropeginteron alfa-2b-njft label to include patients with ET is ongoing, and we are prepared to expand commercialization into this important patient population, pending approval.”
The NCCN is a not-for-profit alliance of leading cancer centers in the United States, and its Clinical Practice Guidelines in Oncology are among the most widely respected and frequently referenced treatment guidelines by U.S. oncologists and hematologists. NCCN Guidelines also play a critical role in informing coverage and reimbursement decisions by public and private payers.
About PharmaEssentia
PharmaEssentia USA Corporation, located in Burlington, Massachusetts, is a subsidiary of PharmaEssentia Corporation (TWSE: 6446). PharmaEssentia Corporation, headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator and the developer and owner of BESREMi® (ropeginterferon alfa-2b-njft). Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan.
For more information about PharmaEssentia USA, visit the website, LinkedIn or X (formerly Twitter).
About Essential Thrombocythemia (ET)
Essential thrombocythemia is a rare blood disorder and type of myeloproliferative neoplasm (MPN). It is characterized by the bone marrow overproducing platelets. Patients with ET are at an increased risk of blood clots, abnormal bleeding and enlarged spleens. ET is often caused by genetic mutations such as a JAK2 genetic mutation.
About BESREMi® (ropeginterferon alfa-2b-njft)
Ropeginterferon alfa-2b-njft is currently FDA-approved and marketed as BESREMi® for the treatment of adults with polycythemia vera (PV). The Company plans to seek a ropeginterferon alfa-2b-njft label expansion to include ET and has submitted a sBLA with the U.S. FDA.
BESREMi® holds orphan drug designation in the United States for the treatment of polycythemia vera (PV) in adults. It has received regulatory approval in over 40 countries, including from the European Medicines Agency (2019), the U.S. Food and Drug Administration (2021), and the Pharmaceuticals and Medical Devices Agency in Japan (2023). The product was developed by PharmaEssentia. PharmaEssentia retains full global intellectual property rights across all indications.
INDICATION
BESREMi® is indicated for the treatment of adults with polycythemia vera.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DISORDERS
Interferon alfa products may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Therapy should be withdrawn in patients with persistently severe or worsening signs or symptoms of these conditions. In many, but not all cases, these disorders resolve after stopping therapy.
CONTRAINDICATIONS
Existence of or history of severe depression, suicidal ideation, or suicide attempt
Hypersensitivity to interferons or any inactive ingredients
Moderate or severe hepatic impairment
History or presence of active serious or untreated autoimmune disease
History of transplantation and receiving immunosuppressant agents
WARNINGS AND PRECAUTIONS
Patients exhibiting the following events should be closely monitored and may require dose reduction or discontinuation of therapy:
- Depression and Suicide: Monitor closely for symptoms and need for treatment.
- Endocrine Toxicity: Discontinue if endocrine disorders occur that cannot be medically managed.
- Cardiovascular Toxicity: Avoid use in patients with severe, acute or unstable cardiovascular disease. Monitor patients with history of cardiovascular disorders more frequently.
- Decreased Peripheral Blood Counts: Perform blood counts at baseline, every 2 weeks during titration, and at least every 3-6 months during maintenance treatment.
- Hypersensitivity Reactions: Stop treatment and immediately manage reaction.
- Pancreatitis: Consider discontinuation if confirmed pancreatitis
- Colitis: Discontinue if signs or symptoms of colitis
- Pulmonary Toxicity: Discontinue if pulmonary infiltrates or pulmonary function impairment
- Ophthalmologic Toxicity: Advise patients to have eye examinations before and during treatment. Evaluate eye symptoms promptly and discontinue if new or worsening eye disorders.
- Hyperlipidemia: Monitor serum triglycerides before BESREMi® treatment and intermittently during therapy and manage when elevated.
- Hepatotoxicity: Monitor liver enzymes and hepatic function at baseline and during treatment. Reduce dose or discontinue depending on severity.
- Renal Toxicity: Monitor serum creatinine at baseline and during therapy. Discontinue if severe renal impairment develops.
- Dental and Periodontal Toxicity: Advise patients on good oral hygiene and to have regular dental examinations.
- Dermatologic Toxicity: Consider discontinuing if clinically significant dermatologic toxicity.
- Driving and Operating Machinery: Advise patients to avoid driving or using machinery if they experience dizziness, somnolence, or hallucination.
Please see full Prescribing Information, including Boxed Warning.
Contacts
Media
Muriel Huang
Director, Investor Relations and Corporate Communication
[email protected]
