Eight months after the last listing application failed, Pharma Essentia successfully alleviated the concerns of the US FDA. Recently, the company's Besremi has been approved by the US FDA for the treatment of polycythemia vera.

In March of this year, the US FDA sent a complete response letter to the biopharmaceutical company in Taiwan Province, China, requesting the company to provide more information about the prefilled syringe instructions used to administer the drug. Some analysts pointed out at that time that given that the US FDA did not request additional data on its clinical data at that time, this was a positive and promising sign for the approval of the therapy in the future.

The US FDA approval is based on the safety of PEGINVERA and PROUD/CONTINUATION-PV studies and the efficacy data from the PEGINVERA clinical research program. The results of the study showed that after 7.5 years of BESREMi treatment, 61% of PV patients experienced a complete hematological response. More importantly, 80% of patients achieved a hematological response.

The injected drug is approved to treat adult patients with polycythemia vera, a rare blood disease that causes blood to thicken and affects approximately 6,200 people in the United States each year. This disease can also cause excessive red blood cell production, slow blood flow and increase the patient's chances of blood clots, strokes and heart attacks. MPNA dvocacyand Education International CEO Ann Brazeau said in a statement that the reality of patients with rare chronic tumors like polycythemia vera is that the disease is often under-recognized and the limited treatments available cannot correct the symptoms. Other diseases.

In addition, Pharma Essentia said that the US FDA’s previous refusal was due to the delay of pre-approval inspections of its manufacturing plant in Taiwan Province of China due to travel restrictions on the COVID-19 pandemic. Besremi was approved in Europe in 2019 and became the first drug approved by the US FDA to treat polycythemia vera, and patients can take it regardless of their treatment history. The drug is also the first interferon drug approved for the treatment of this disease.

The therapy can bind to interferon receptors and trigger the process of reducing red blood cell production in the bone marrow. Patients take Besremi once every two weeks. If the production of red blood cells is successfully reduced after one year, the patient can reduce the dose to once a month. However, this rare disease drug carries a black box warning, detailing the risk of serious effects that may occur after treatment, including the deterioration of neurological and mental disorders, autoimmunity, ischemia, and infectious diseases. Once the medication is started, the patient must be closely monitored for these symptoms.

In terms of competitors, Incyte's Jakafi was approved as a second-line treatment for polycythemia vera, while Besremi approved the first-line treatment this time.