What is Elonva?
Elonva is a solution for injection that contains the active substance corifollitropin alfa. It is available as a pre-filled syringe (100 and 150 micrograms).
What is Elonva used for?
Elonva is used in women undergoing fertility treatment to stimulate the simultaneous maturation of multiple eggs in the ovaries. It is used together with an antagonist of the hormone GnRH (gonadotropin-releasing hormone), which is another medicine used in fertility treatments.
Elonva can only be obtained with a prescription.
How is Elonva used?
Treatment with Elonva should be started under the supervision of a doctor experienced in treating fertility problems.
Elonva is given only once by subcutaneous injection. Patients weighing no more than 60 kg should take the 100 microgram dose, while higher weight patients should take the 150 microgram dose. The injection can be made by the patient herself or by the partner if properly instructed.
Four to five days after the injection, depending on the ovarian response, treatment with a GnRH-antagonist should be initiated in order to prevent premature release of the eggs. Seven days after the injection, if it is necessary to further stimulate the ovaries, it is possible to inject another drug similar to Elonva but suitable for daily administration. When there are three eggs about to mature, a single injection of the hormone hCG (human chorionic gonadotropin) is given to cause the release of the mature eggs.
The eggs are taken with a surgical procedure, then fertilized in the laboratory. The embryo thus obtained is transferred to the uterus.
How does Elonva work?
The active ingredient contained in Elonva, corifollitropin alfa, is a modified version of the hormone FSH (follicle stimulating hormone), naturally present in the body. FSH stimulates egg production in the ovaries. In corifollitropin alfa, a peptide (a short chain of amino acids) binds to FSH, prolonging its activity in the body. Consequently it is sufficient to administer a single dose of the medicine to stimulate the production of eggs, thus renouncing the practice of daily injections required by other FSH-based drugs.
Corifollitropin alfa is produced with the so-called "recombinant DNA technology", that is it is produced by a cell in which a gene (DNA) has been inserted and which has thus become able to produce a protein, in this case the corifollitropina alfa
What studies have been carried out on Elonva?
The effects of Elonva were first tested in experimental models before being studied in humans. In two main studies involving 1 905 patients with need for ovarian stimulation, treatment with Elonva was compared with treatment with follitropin beta (a medicine based on FSH also used to stimulate the ovaries). One of the studies was carried out on patients weighing no more than 60 kg and treated with Elonva 100 micrograms, while the other study involved patients weighing over 60 kg and treated with the 150 micrograms dose. The main efficacy parameter of both studies was the average number of eggs taken from a single patient after treatment. One of the studies envisaged, as a further main parameter of efficacy, the number of patients who had established a pregnancy. The other study was not large enough to allow solid conclusions on established pregnancies.
What benefit has Elonva shown during the studies?
Treatment with Elonva was as effective as treatment with follitropin beta. In the study on patients weighing more than 60 kg, an average of 13.7 eggs per patient treated with Elonva and 12.5 eggs per patient treated with follitropin beta were taken. Approximately 39% of patients treated with Elonva developed a pregnancy, compared with 38% of patients treated with follitropin beta.
In the study of patients weighing no more than 60 kg, an average of 13.3 eggs per patient treated with Elonva and 10.6 eggs per patient treated with follitropin beta were taken.
What are the risks associated with Elonva?
The most common side effects with Elonva (seen in between 1 and 10 patients in 100) are headache, nausea, fatigue, pelvic pain and discomfort, breast disorders and ovarian hyperstimulation syndrome (OHSS). The latter occurs if the ovaries over-respond to treatment resulting in abdominal swelling and pain, nausea and diarrhea. For the full list of all side effects reported with Elonva, see the Package Leaflet.
Elonva should not be used in patients who may be hypersensitive (allergic) to corifollitropin alfa or any of the other ingredients. It should also not be used in patients with cancers of the ovary, breast, uterus, pituitary gland (the gland located at the base of the brain that produces FSH) or hypothalamus (an area of the brain). It should also not be used in patients with primary ovarian failure, ovarian enlargement or ovarian cysts or with previous cases of OHSS. For the full list of usage restrictions, see the package leaflet.
Why was Elonva approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Elonva's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Elonva
On 25 January 2010, the European Commission issued a marketing authorization for Elonva to NV Organon, valid throughout the European Union. The marketing authorization is valid for five years and is renewable.
For the full EPAR for Elonva, click here.
Last update of this summary: 12-2009.
