FDA approves Hizentra 50 mL prefilled syringes for primary immunodeficiency treatment
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Key takeaways:
- Hizentra is approved for treating patients with primary immunodeficiency aged 2 years and older.
- The immune globulin also is approved for adults with chronic inflammatory demyelinating polyneuropathy.
The FDA has approved 50 ml/10 gm prefilled syringes of Hizentra for treating patients with primary immunodeficiency aged 2 years and older and adults with chronic inflammatory demyelinating polyneuropathy, according to a press release.
Hizentra (immune globulin subcutaneous [human] 20% liquid; CSL Behring) is the first and only immune globulin available in a prefilled syringe designed to be simple, convenient and ready to use, according to the release.
“When managing a lifelong rare disease or chronic condition, it is important to have treatment options that offer flexibility and convenience, as a person’s needs can change over time,” Lisa Butler, executive director of the GBS|CIDP Foundation, said in the press release.
“Having prefilled syringes available that allow people with conditions such as [chronic inflammatory demyelinating polyneuropathy (CIDP)] to administer their treatment at home, on their schedule, can help decrease treatment burden,” Butler said.
Treatment for primary immunodeficiency and CIDP depends upon many factors, a company spokesperson told Healio. One possible treatment, immune globulin, can be administered intravenously or subcutaneously.
Intravenous treatments are usually administered at a treatment center, while subcutaneous treatments can be self-administered at home.
CSL Behring reports that Hizentra is the most prescribed self-infused subcutaneous immune globulin (SCIg) treatment for primary immunodeficiency in the United States as well as the first and only SCIg treatment approved for CIDP. Also, CSL Behring cited clinical programs establishing Hizentra’s efficacy and safety profile.
The company expects the 50 mL syringe to be available in early 2024, joining its line of 5 mL, 10 mL and 20 mL prefilled syringes as well as its 5 mL, 10 mL, 20 mL and 50 mL vials. The dose that patients need to manage their condition varies, the spokesperson further told Healio, with the lineup enabling a range of simple, convenient and ready-to-use options for people with primary immunodeficiency or CIDP.
CSL Behring said that it is also studying Hizentra’s use in treating systemic sclerosis in a phase 2 trial and dermatomyositis in a phase 3 trial as well.