Overview
Corifollitropin alfa, also known as Elonva is used in women undergoing fertility treatment to stimulate the development of more than one mature egg (oocyte) at a time in the ovaries. This drug used together with a gonadotropin-releasing hormone (GnRH) antagonist, a type of medicine also used in fertility treatments. Elonva is available only by prescription . In July 2014, Merck announced the receipt of a Complete Response Letter (CRL) from the U.S. FDA for its New Drug Application for this drug. Corifollitropin alfa is marketed as Elonva in more than 75 countries . Corifollitropin alfa is produced by a method known as ‘recombinant DNA technology’. This means that it is made by cells into which a DNA has been introduced that makes them able to produce corifollitropin alfa . Multiple studies and a meta-analysis suggest that corifollitropin alfa is as efficacious as recombinant FSH in terms of live birth rate, ongoing pregnancy rate, as well as clinical pregnancy rate. The increased in the number of eggs retrieved under corifollitropin alfa regimen represents the elevated effectiveness of this drug, however, warns at the same time against the possibility of an increased risk of ovarian hyperstimulation in the high responder study group of women , .
Indication
Controlled ovarian stimulation in cases of women who are undergoing fertility treatment to stimulate the development of more than one mature egg simultaneously in the ovaries in combination with a gonadotrophin-releasing hormone (GnRH) antagonist (a type of medicine also used in fertility treatments).
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/19 | Phase 4 | Not yet recruiting | |||
2023/04/18 | Phase 4 | Completed | Instituto Bernabeu | ||
2021/01/05 | Phase 4 | Completed | |||
2020/07/23 | N/A | Recruiting | |||
2020/06/04 | Not Applicable | Completed | |||
2019/10/29 | N/A | Completed | Kinderwunsch Institut GmbH | ||
2019/01/25 | Not Applicable | Completed | University of Turin, Italy | ||
2017/07/06 | Phase 4 | Completed | AZ Jan Palfijn Gent | ||
2017/06/23 | Phase 3 | Completed | |||
2017/01/12 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/25/2010 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Elonva Solution for Injection 150mcg/0.5ml | SIN13940P | INJECTION, SOLUTION | 0.150mg | 3/31/2011 | |
| Elonva Solution for Injection 100mcg/0.5ml | SIN13939P | INJECTION, SOLUTION | 0.100mg | 3/31/2011 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ELONVA SOLN FOR INJ 150MCG/0.5ML (PRE-FILLED SYRINGE) | N/A | N/A | N/A | 7/22/2011 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ELONVA corifollitropin alfa 150 micrograms/0.5mL solution for injection prefilled syringe | 160645 | Medicine | A | 7/30/2010 | |
| ELONVA corifollitropin alfa 100 micrograms/0.5mLsolution for injection prefilled syringe | 160646 | Medicine | A | 7/30/2010 |
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