Drugs / CUTAQUIG
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT03939533 | Oct 2019 → Jan 2022 | inborn error of immunity | Octapharma | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03677557 | Sep 2018 → Aug 2021 | acquired immunodeficiency, inborn error of immunity | Ottawa Hospital Research Institute | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2023-05-23 | Octapharma | Results Journal of Clinical Immunology Publishes Octapharma USA Research on cutaquig® Evaluating PI Treatment Options octapharma.com ↗
The majority of patients in the study found the new investigational infusion regimens to be better or somewhat better than their previous regimens |
| 2022-01-18 | Octapharma | Regulatory European authorities expand the indication for cutaquig® for patients with secondary immunodeficiencies octapharma.com ↗
Octapharma announced today that the indication for cutaquig®, a human immunoglobulin for subcutaneous administration, has been expanded in the European Union (EU), providing more flexible treatment options to a far-wider range of patients with acquired immune deficiencies. |
| 2020-09-15 | Octapharma | Regulatory Octapharma USA Announces Medicare Part B Approval of cutaquig® 16.5% for Adult PI Patients octapharma.com ↗
Octapharma USA today announced the Centers for Medicare & Medicaid Services (CMS) has modified the External Infusion Pump Local Coverage Determination to include cutaquig® 16.5%, the company’s subcutaneous immunoglobulin (SCIg), for use with electric and mechanical pumps. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-05-23 | Octapharma | Journal of Clinical Immunology Publishes Octapharma USA Research on cutaquig® Evaluating PI Treatment Options octapharma.com ↗ |
| 2022-01-18 | Octapharma | European authorities expand the indication for cutaquig® for patients with secondary immunodeficiencies octapharma.com ↗ |
| 2020-09-15 | Octapharma | Octapharma USA Announces Medicare Part B Approval of cutaquig® 16.5% for Adult PI Patients octapharma.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cutaquig | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03677557 ↗ |
| Modality | Protein / enzyme biologic | “Polyvalent immunoglobulin treatment” NCT03677557 ↗ |
| Route | Subcutaneous | “licensed for subcutaneous administration” NCT03677557 ↗ |