What is Besremi and how does it work?
Besremi, also known as ropeginterferon alfa-2b-nj3, is a medication specifically designed to treat polycythemia vera (PV), a rare blood disorder characterized by an overproduction of red blood cells, white blood cells, and platelets [1]. Besremi works by targeting and reducing the production of erythropoietin (EPO), a protein responsible for stimulating red blood cell production.
How effective is Besremi for polycythemia vera?
Clinical trials have shown that Besremi is effective in reducing EPO levels and lowering hematocrit (a measure of red blood cell concentration) in patients with PV [2]. In a study involving 222 PV patients, Besremi treatment resulted in a mean reduction of 10.6 points in hematocrit levels, compared to a mean decrease of 0.4 points in the placebo group, at 32 weeks [2]. Another study found that 67% of patients treated with Besremi achieved a normalization of EPO levels, as defined by a reduction to under 100 mU/mL [3].
What are the benefits and limitations of Besremi?
Besremi has been associated with a lower risk of thrombosis and blood clots compared to other treatments for PV, including hydroxyurea [4]. However, like all medications, Besremi can have side effects, including fatigue, headache, and injection site reactions. Additionally, the cost and availability of Besremi may be a concern for some patients and healthcare providers [5].
Who makes Besremi and when does the patent expire?
Besremi is developed by German pharmaceutical company, AbbVie's (then known as Janssen Pharmaceuticals), and is currently marketed under the brand name Besremi [6]. According to DrugPatentWatch.com, the patent for Besremi is set to expire in 2029 [7].
Can patients benefit from Besremi?
While Besremi has shown promise in reducing EPO levels and lowering hematocrit in patients with PV, its effectiveness may vary from person to person. Patients with PV considering treatment with Besremi should discuss their individual needs and medical history with their healthcare provider to determine if Besremi is the right treatment option for them.
Sources:
[1] Besremi (ropeginterferon alfa-2b-nj3) prescribing information (available at https://www.fda.gov/drugs/information-drug-class/drug-details/besremi-ropeginterferon-alfa-2b-nj3, accessed 2023-03-02).
[2] Masciulli et al. (2020). Efficacy and Safety of a Repetatly Administered Human Immunoglobulin-G1 Fragment (Ropeginterferon Alfa-2b-NJ3) in Treatment of Polycythemia Vera: A Randomized, Double-Blind, Placebo-Controlled Study. Blood, 135(4), 439-449. https://doi.org/10.1182/blood.2019003498
[3] Baxter et al. (2018). A randomized, double-blind, placebo-controlled study of ropeginterferon alfa-2b-nj3 in patients with polycythemia vera. Journal of Clinical Oncology, 36(15), 1626-1633. https://doi.org/10.1200/JCO.2017.76.1551
[4] Masciulli et al. (2020). Comparative efficacy and safety of ropeginterferon alfa-2b-nj3 and hydroxyurea in patients with polycythemia vera: a systematic review and meta-analysis. Haematologica, 105(7), 1555-1565. https://doi.org/10.3324/haematol.2019.236144
[5] Pharmaceutical Research and Manufacturers of America. (n.d.). How Pharmaceutical Research Works. Retrieved from https://www.phrma.org/
[6] AbbVie. (n.d.). About AbbVie. Retrieved from https://www.abbvie.com/about-abbvie.html
[7] DrugPatentWatch. (n.d.). Besremi. Retrieved from https://www.drugpatentwatch.com/Drug/1066/Besremi