Advate

Advate (octocog alfa) is a treatment used to control and prevent bleeding episodes in adults and children with hemophilia A. It is marketed by Takeda Pharmaceuticals and was approved by the U.S. Food and Drug Administration in 2003.

How does Advate work?

Advate contains a substance called octocog alfa — a recombinant, or lab-made, form of clotting factor VIII (FVIII), the clotting protein that is missing or is defective in people with hemophilia A. The clotting factor contained within Advate is able to replace naturally produced FVIII, allowing for the control and prevention of bleeds in patients with hemophilia A.

Advate may also be administered before surgical procedures to prevent excessive bleeding.

Advate in clinical trials

Advate’s original approval in 2003 was based on results from Phase 2/3 clinical trials evaluating its safety and efficacy on bleed treatment and prevention in previously treated hemophilia patients.

A main study involving 111 patients compared Advate with another approved therapy called Recombinate, to assess if the two medicines were equivalent.

The study evaluated the number of bleeding episodes and rated Advate’s effectiveness in stopping bleeds on a scale from none to excellent. Advate’s effectiveness was considered excellent or good in 86% of 510 new bleeding events. Additionally, 81% of these episodes required only a single treatment with Advate.

The approval of Advate as a routine prophylactic, or preventive, treatment in 2011 came after the results of a Phase 4 study comparing two prophylactic regimens to an on-demand treatment regimen. A total of 53 patients with severe or moderately severe hemophilia A were included in this study.

Results showed that Advate significantly reduced median annual bleeding rate (44 to one) when compared with an on-demand regimen. The study also found that 42% of patients had zero bleeding episodes over one year on prophylaxis.

Data from 12 clinical trials (Phase 1 through 4) were analyzed to assess the safety and tolerability of Advate in treating severe hemophilia A in children and adults. The study covered data over more than 10 years and included 418 patients.

Results showed that most adverse events associated with Advate were not serious. From those considered serious, the most common were related to the development of inhibitors (neutralizing antibodies) against FVIII, device-related infection, and fever. No deaths or cases of hypersensitivity were observed.

Other details

Advate is available in single-use bottles containing 250, 500, 1,000, 1,500, 2,000, 3,000, and 4,000 international units (IU).

The treatment is injected directly into a vein. Injection frequency depends on the type of bleed and physician recommendation. For prophylactic treatment, patients should be given a dose between 20 to 40 IU per kg every other day (three to four times a week). A dose aimed at maintaining FVIII levels at 1% or higher may be given once every three days.

The most common adverse events associated with Advate include fever, headache, cough, throat inflammation, vomiting, joint stiffness, and limb injury.

Patients may develop a severe allergic reaction to the treatment. Advate is contraindicated, or not recommended, for people with known severe allergies to mouse or hamster proteins or to other therapy components.

Patients may also develop neutralizing antibodies against FVIII, making Advate less effective.

 

Last updated: Jan. 27, 2022, by Teresa Carvalho MS

 


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