October 4, 2023

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FDA approves Besremi: The first PV interferon drug

FDA approves Besremi: The first PV interferon drug



FDA approves Besremi: The first PV interferon drug.

Recently, FDA approved the long-acting interferon preparation Besremi (generic name ropeginterferon alfa-2b-njft) of Taiwan biopharmaceutical company: Pharmaessentia for the treatment of adult polycythemia vera (PV).


This approval is based on the results of a phase III clinical trial called PEGINVERA. 80% of the patients in the medication group achieved hematological response and 61% of patients had a complete response.

Common side effects include cold-like symptoms, fatigue, and itching. This product has been listed in Europe before, but the listing application in the United States has received a CRL due to the impact of the COVID-19.


FDA approves Besremi: The first PV interferon drug.




Drug source analysis

PV is a red blood cell proliferative disease, a type of myeloproliferative tumor (MPN). The incidence of this disease is not high, only one in 100,000, but because the fatality rate is low, there are many patients, and there are millions of patients worldwide. JAK2V617 mutation is the main feature, JAK2 inhibitor rucotinib has been approved for PV therapy.

In addition to this targeted therapy as a last-line therapy, the early treatment of PV relies on some older therapies such as hydroxyurea, interferon, etc.

Although these old drugs are not supported by strictly controlled trial data, they are also commonly used clinically.

Although Besremi is the first officially approved PV interferon preparation, it is based on years of experience in clinical use of other interferon products, so the technical risk is relatively low.


Although PV is a tumor, the main risk is cardiovascular disease caused by coagulopathy, and half of the patients die as a result. In addition, if PV is not treated in time, it will increase the risk of more serious tumors such as AML. PV is a stem cell disease, mainly due to the excessive proliferation of red blood cells caused by the imbalance of differentiation.

The first-line treatment is bloodletting surgery. Bloodletting is obviously to dilute all blood cells non-selectively. The ideal treatment technique should selectively eliminate malignant clones. Interferon has been used clinically to treat PV for decades and can reduce the frequency of bloodletting operations.

Later, it was discovered that one of the mechanisms was to selectively eliminate malignant clones such as JAK2V617 mutations. Interferon is also used in the treatment of CML that is positive for the Philadelphia mutation (BCL-ABL, and the PV is negative for the Philadelphia mutation).

Of course, the most important application of interferon is antiviral. For example, interferon is the main therapeutic component before the market of hepatitis C magic drug. In the past two years, interferon is often used in the treatment of COVID-19s.


The side effects of interferon are the main factor limiting its use. Therefore, although the treatment of hepatitis C is effective, the patient’s quality of life is also very expensive. Sovaldi’s removal of interferon from the treatment of hepatitis C is indeed a joy for the patients. But not all diseases have Sovaldi’s curative effect in hepatitis C.

It is still a helpless choice to continue to improve interferon. Pegylation (Peg) is a common chemical method that prolongs the half-life and reduces the peak-to-valley difference in blood concentration (thus reducing side effects). Besremi is a single-Pegated interferon with a long half-life and can be administered once every two weeks.

Many endogenous cytokines with short half-lives have improved safety through Pegization. In the past few years, Nektar, which was famous for the development of selective IL-2 preparations NKTR214, is an enterprise that uses Pegization as a technology platform.


In general, Besremi utilizes many years of experience in the use of interferon outside the label of PV in the mechanism, and technically uses the mature half-life extension technology of Peg, and the disease chooses PV, a tumor that is less lethal and less competitive. This should be the lowest risk strategy for the first drug on the market.





(source:internet, reference only)

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