奥拉迪约在国内获批上市了吗？

Oradejo is a plasma kallikrein inhibitor that binds to plasma kallikrein and inhibits its proteolytic activity. In patients with HAE due to C1 deficiency or dysfunction of the inhibitor (C1-INH), plasma kallikrein activity is not regulated normally, which leads to an uncontrolled increase in plasma kallikrein activity and leads to angioedema attack. Will reduce plasma kallikrein activity to control excessive bradykinin production in patients hospitalized with HAE. So, has Oladiyo been approved for listing in the country?

The U.S. Food and Drug Administration (FDA) has approved oral, once-daily Oradejo prophylaxis to prevent the onset of hereditary angioedema (HAE) in adults and children 12 years of age and older. But it is not yet available in the country.

In the pivotal Phase 3 APeX-2 trial, Oladijo (150 mg once daily) significantly reduced the number of HAE episodes over 24 weeks and continued through week 48. Patients who completed the 48-week trial experienced a significant reduction in the frequency of HAE attacks, from an average of 2.9 attacks/month at baseline to an average of 1 attack/month. Patients who completed another long-term open-label APeX-S study reported a reduction in HAE attack frequency to an average of 0.8 episodes/month.

Oradejo was safe and well-tolerated in both studies, with the most common adverse reaction compared with placebo being gastrointestinal. Usually the incidence is higher in the early stages of treatment, then gradually decreases, and patients usually resolve on their own.

Oladiyo is the first targeted oral therapy approved to prevent HAE attacks. The approval of Oladiyo will bring significant progress in the treatment of HAE patients with hereditary angioedema and will help reduce the treatment burden on patients.

Recommended dose of Oradejo: Take one capsule (150 mg) once daily with food. Patients should not increase or decrease the drug dosage without authorization while receiving Oladiyo treatment. Increasing the drug dosage will not make the condition improve quickly, but will lead to adverse reactions. Therefore, patients should strictly follow the doctor's diagnosis and treatment recommendations and should not use medication without authorization. Patients who are allergic to any of the ingredients should not use this medicine for treatment.

Note: The above information comes from the Internet and is compiled and edited by Medical Companion Travel (please correct me if there are any errors or omissions). It is only to provide information on the latest drugs on the market in the world and help Chinese patients understand the latest international new drug trends. It is only for internal discussion among medical staff and does not serve as any basis for medication. For specific medication guidelines, please consult the attending physician.