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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/971205/2011

EMEA/H/C/001042

EPAR summary for the public

Fertavid

foMitropin beta

This is a summary of the European public assessment report (EPAR) for Fertavid. 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 Fertavid.

What is Fertavid?

Fertavid is a solution for injection that contains the active substance follitropin beta.

This medicine is the same as Puregon, which is already authorised in the European Union (EU). The

company that makes Puregon has agreed that its scientific data can be used for Fertavid.

What is Fertavid used for?

Fertavid is used to treat infertility in women in the following situations:

•    women who are anovulatory (do not produce eggs) and do not respond to treatment with clomiphene citrate (another medicine that stimulates ovulation);

•    women who are undergoing fertility treatment (assisted reproductive techniques, such as in vitro fertilisation). Fertavid is administered to stimulate the ovaries to produce more than one egg at a time.

Fertavid can also be used to stimulate sperm production in men who have hypogonadotrophic

hypogonadism (a rare hormone deficiency disease).

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Fertavid can only be obtained with a prescription.

How is Fertavid used?

Treatment with Fertavid should be carried out by a doctor who has experience in the treatment of fertility problems. Fertavid is given as an injection under the skin or into a muscle. The patient or their partner may carry out the injections. Fertavid should only be administered by people who have been trained by the doctor and have access to expert advice. The dose and frequency of administration of Fertavid depend on its use (see above) and the patient's response to treatment. For a full description of the doses, see the package leaflet.

How does Fertavid work?

The active substance in Fertavid, follitropin beta, is a copy of the natural hormone follicle stimulating hormone (FSH). In the body, FSH regulates reproductive function: in women, it stimulates the production of eggs, and in men, it stimulates the production of sperm by the testicles. Previously, the FSH used as a medicine was extracted from urine. The follitropin beta in Fertavid is produced by a method known as 'recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.

How has Fertavid been studied?

Fertavid's use in women undergoing fertility treatment has been studied in 981 patients. The number of eggs recovered and the ongoing pregnancy rate were the main measures of effectiveness. Fertavid was studied in 172 anovulatory women, measuring how many cycles of treatment were needed for these women to ovulate. In men, Fertavid was studied to see its effect on sperm production in 49 patients. In all of the studies, Fertavid was compared with the natural FSH hormone that was extracted from urine.

What benefit has Fertavid shown during the studies?

Fertavid was as effective as the comparator in all of the studies. Fertavid was as effective as urinary FSH as a fertility treatment, in producing ovulation and in producing sperm.

What is the risk associated with Fertavid?

The most common side effects with Fertavid are a reaction and pain at the injection site. In 4% of the women treated with Fertavid in clinical studies, signs and symptoms related to ovarian hyperstimulation syndrome (e.g. feeling sick, weight gain and diarrhoea) have been reported. Ovarian hyperstimulation syndrome occurs when the ovaries over-respond to treatment. Doctors and patients must be aware of this possibility. For a full list of all side effects reported with Fertavid, see the package leaflet.

Fertavid should not be used in people who may be hypersensitive (allergic) to follitropin beta or any of the other ingredients. Fertavid must not be used in patients with tumours of the ovary, breast, womb, testicle, pituitary gland or hypothalamus. It must not be used in men with testicular failure. In women, it must not be used when there is ovarian failure, ovarian enlargement or the presence of cysts that are not due to polycystic ovarian disease, or vaginal bleeding. For the full list of restrictions, see the package leaflet.

Fertavid

Why has Fertavid been approved?

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

Other information about Fertavid

The European Commission granted a marketing authorisation valid throughout the European Union for Fertavid on 19 March 2009.

The full EPAR for Fertavid 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 Fertavid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 12-2011.

Fertavid

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