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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/378798/2015

EMEA/H/C/001106

EPAR summary for the public

Elonva

corifollitropin alfa

This is a summary of the European public assessment report (EPAR) for Elonva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Elonva.

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 who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries. It is used together with a gonadotrophin-releasing hormone (GnRH) antagonist (a type of medicine also 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 once as a single injection under the skin in a dose of 100 or 150 micrograms, depending on age and body weight. The patient or their partner may carry out the injection if they have been properly instructed. For further details, see the package leaflet.

Four or five days after the Elonva injection, depending on how the ovaries have responded, treatment is started with a GnRH antagonist, which prevents the ovaries from releasing their eggs too early. Seven days after the Elonva injection, if further ovarian stimulation is needed, injections of another

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medicine similar to Elonva, but suitable for daily injection, may be given. Finally, as soon as three eggs are close to maturation, a single injection of a hormone called human chorionic gonadotropin (hCG) is given to release the mature eggs.

The eggs are collected using a surgical procedure. They will then be fertilised in a laboratory and the resulting embryo is implanted in the womb.

How does Elonva work?

The active substance in Elonva, corifollitropin alfa, is similar to follicle stimulating hormone (FSH), a natural hormone in the body. FSH stimulates the production of eggs in the ovaries. In corifollitropin alfa, a peptide (a short chain of amino acids) is attached to the FSH to prolong its activity in the body. As a result a single dose of the medicine can be given to stimulate egg production for seven days, thereby replacing daily injections that would be required with other FSH medicines.

Corifollitropin alfa is produced by a method known as 'recombinant DNA technology'. This means that it is made by cells into which a gene (DNA) has been introduced that makes them able to produce corifollitropin alfa.

How has Elonva been studied?

In three main studies involving 3,292 women who needed to have ovarian stimulation, Elonva treatment was compared with treatment with follitropin beta (an FSH medicine also used to stimulate the ovaries).

One of the studies involved women weighing 60 kg or less who received a 100-microgram dose of Elonva, and a second study involved women weighing above 60 kg who received a 150-microgram dose. Both these studies involved women aged 18 to 36 years. The main measure of effectiveness for these studies was the average number of eggs collected from each woman after treatment. The study in women over 60 kg had an additional main effectiveness measure which was the number of women with a successful early pregnancy.

The third study involved women in the age range 35 to 42 years weighing 50 kg or more who were given a 150-microgram dose of Elonva; the main measure of effectiveness in this study was the number of women with a successful early pregnancy.

What benefit has Elonva shown during the studies?

Treatment with Elonva was as effective as treatment with follitropin beta.

In the first study in women weighing 60 kg or less, the number of eggs collected from each woman was 13.3 for those treated with Elonva and 10.6 for those treated with follitropin beta.

In the second study in women weighing above 60 kg, the average number of eggs collected from each woman was 13.8 in those treated with Elonva compared with 12.6 in those treated with follitropin beta. Around 39% of those who received Elonva became pregnant compared with 38% of those treated with follitropin beta.

In the third study in women weighing 50 kg or more, 24 and 27% of women treated with Elonva and follitropin beta respectively became pregnant.

What is the risk associated with Elonva?

The most common side effects with Elonva (seen in between 1 and 10 patients in 100) are headache, nausea (feeling sick), tiredness, pelvic pain and discomfort, breast tenderness and ovarian hyperstimulation syndrome (OHSS). OHSS occurs when the ovaries over-respond to treatment, causing abdominal swelling and pain, nausea and diarrhoea. For the full list of all side effects reported with Elonva, see the package leaflet.

Elonva must not be used in patients with tumours of the ovary, breast, womb, pituitary (a gland located at the base of the brain that produces FSH) or hypothalamus (a region of the brain). It must also not be used in women with abnormal (not menstrual) bleeding from the vagina without a known cause, primary ovarian failure, enlarged ovaries or ovaries with cysts, polycystic ovarian syndrome or in women with a history of OHSS. For the full list of restrictions, see the package leaflet.

Why has Elonva been approved?

The CHMP decided that Elonva's benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Elonva?

A risk management plan has been developed to ensure that Elonva is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Elonva, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about Elonva

The European Commission granted a marketing authorisation valid throughout the European Union for Elonva on 25 January 2010.

The full EPAR for Elonva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with Elonva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 10-2014.

Elonva

EMA/378798/2015

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