PharmaEssentia Announces FDA Approval and U.S. Launch of BESREMi Pen™ (ropeginterferon alfa-2b-njft) for Polycythemia Vera

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 the U.S. Food and Drug Administration (FDA) approval and launch of the BESREMi Pen™ (ropeginterferon alfa-2b-njft) device for adult patients with polycythemia vera (PV). The device offers a more convenient self-administration option than the currently available pre-filled syringe. The BESREMi Pen™ is expected to become commercially available in the U.S. in the coming weeks.

“The U.S. approval of the BESREMi Pen™ is a significant milestone both for our company, as well as the patients we serve,” said Samuel Lin, Head of Global Operations, PharmaEssentia. “With this new device, we’re empowering more people living with PV to manage their condition with greater ease and confidence. It reflects our continued commitment to delivering not only innovative therapeutics, but also smarter, more intuitive ways to support long-term care.”

“I’m very excited to see the FDA approval of the BESREMi Pen™ as a new option for patients,” said Dr. John Mascarenhas, Director of the Center of Excellence for Blood Cancers and Myeloid Disorders at Mount Sinai in New York City. “Treatment consistency is critical for managing PV, and this device has the potential to make a meaningful positive impact on patients’ lives by simplifying self-administration and supporting better adherence.”

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. 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 Polycythemia Vera (PV)

Polycythemia vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells and platelets. PV may result in cardiovascular complications such as thrombosis and embolism, and often transforms to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.

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.