Agamree不同版本一盒的最新价格公布

Agamree (vamorolone) is the first EU fully approved treatment drug for Duchenne muscular dystrophy (DMD). Its price varies significantly due to production standards and regional policies. The following is the current price information of known versions in the global market.

The latest prices of a box of different versions of Agamree are announced

Prices of Swiss original drug

The original Agamree drug produced by Santhera Pharmaceuticals in Switzerland has a specification of 40mg/mL*100mL/box and sells for about US$9,764. This version is already available in the United States, Germany and the United Kingdom and needs to be obtained through cross-border medical channels. The cold chain transportation cost accounts for about 15%-20% of the total cost.

Prices of versions in other countries

At present, there is no official information about the production of Agamree in other countries. Although some Southeast Asian countries are labeled as "international version", they are actually parallel imports of original research drugs, and the prices are basically the same as those in the country of origin. Patients should be wary of false propaganda from unauthorized channels and avoid purchasing ineffective or expired drugs.

After understanding the dynamics of drug prices, patients need to pay attention to the development progress of generic drugs. The following content will analyze the current status of Agamree’s generic drugs.

Are there any generic drugs of Agamree now?

As a new glucocorticoid drug, Agamree currently has no generic drugs on the market globally. Its patent protection and orphan drug status have slowed down the process of imitation.

Patent protection and market exclusivity period

Agamree has obtained EU orphan drug qualification and rare pediatric disease designation, and enjoys 10-year market exclusivity protection (until 2034). Santhera Pharmaceuticals has applied for a number of formulation process patents, covering suspension formulation and delivery device design, further hindering the development of generic drugs.

Generic drug research and development trends

Due to the small population of DMD patients and high research and development costs, international generic drug companies have not yet announced relevant development plans. Indian pharmaceutical company Cipla has expressed interest in this field, but has not yet launched clinical trials. It is expected that there will be no legal imitation versions in the next five years.

After clarifying the source of the drug, patients with abnormal liver function need to pay special attention to the dosage adjustment plan. Specific medication recommendations are described below.

Recommended dosage of Agamree for patients with impaired liver function

Agamree is mainly metabolized by the liver. Patients with abnormal liver function need to adjust the dosage according to the Child-Pugh classification to balance efficacy and safety.

Dosage regimen for mild to moderate hepatic impairment

The recommended dose for patients with Child-Pugh Class A (mild) or Class B (moderate) is 2 mg/kg per day, taken with food. For those weighing more than 50kg, the maximum daily dose should not exceed 100mg. During treatment, ALT, AST and bilirubin levels need to be monitored monthly. If the indicators increase more than 3 times compared with the baseline, medication needs to be suspended until recovery.

Dose restrictions for severe hepatic impairment

There is a lack of clinical use data for patients with Child-Pugh class C (severe), and the instructions do not provide clear dosage recommendations. Such patients need to weigh the risks under the guidance of a liver specialist, adopt a lower starting dose (such as 1mg/kg/day) if necessary, and have their coagulation function and blood ammonia levels tested weekly.

Patients with abnormal liver function should avoid combined use of strong CYP3A4 inhibitors (such as itraconazole) to prevent abnormal increases in plasma concentrations. A low-fat diet is recommended during treatment to reduce the metabolic burden on the liver. If signs of hepatic encephalopathy such as jaundice, ascites, or confusion occur, the drug should be stopped immediately and seek medical treatment. Through personalized dose management and regular monitoring, Agamree can provide effective treatment support for DMD patients with different liver function status.