Fertility treatment offers women fewer daily injections

News Release

Fertility treatment option offers women fewer daily injections

ELONVA® (corifollitropin alfa injection) launched in New Zealand

Auckland. June 24, 2013 – New Zealand women choosing to undergo an assisted reproductive technology (ART) programme may now have a more convenient and less stressful option. One injection of ELONVA, launched in New Zealand this month, may replace seven daily injections of conventional treatment.

ELONVA is the first sustained follicle stimulant treatment for fertility. It is approved for controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women needing to undertake an ART programme.

A single subcutaneous (into tissue under the skin) injection of ELONVA may replace the first seven injections of any conventional daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle.

A reduction in the number of injections may help reduce the physical, psychological and emotional burden that many women suffer when undergoing an ART programme. In a study aimed at understanding how women feel about having experienced In Vitro Fertilisation (IVF) 29% rated having injections as either an extremely or very stressful event. 1

Approved in Europe in 2010 and in Australia in 2011, ELONVA has the ability to initiate and sustain multiple follicular growth for an entire week, and offers similar pregnancy outcomes to rFSH. 2

ELONVA is not however suitable for all women on ART. Each patient is unique and there are many causes of infertility. Women are, therefore, advised to consult their specialist to see if this treatment is suitable for them.

Approval for ELONVA was based upon extensive clinical trial data including ENGAGE, the largest double-blind fertility agent trial in IVF performed to date. In the ENGAGE trial, the ongoing pregnancy rate, the primary endpoint, obtained in the ELONVA treatment arm (38.9 % per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH (38.1 % per started cycle).2

The most frequently reported adverse drug reactions during treatment with ELONVA in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS) (5.2%), pelvic pain (4.1%) and discomfort (5.5%), headache (3.2%), nausea (1.7%), fatigue (1.4%) and breast complaints (including tenderness) (1.2%). Use with GnRH agonists is not recommended.

www.elonva.co.nz

About ELONVA

ELONVA is approved COS in combination with a GnRH antagonist for the development of multiple follicles in women participating in an ART program. ELONVA is designed as a sustained follicle stimulant with the same pharmacodynamic profile as rFSH, but with a markedly prolonged duration of FSH activity. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of ELONVA may replace the first seven injections of any daily rFSH preparation in a COS treatment cycle.

About ENGAGE

ENGAGE was a non-inferiority trial designed to compare ELONVA 150 mcg to 200 IU rFSH. A total of 1,506 patients (with a body weight greater than 60 kg) at 34 in-vitro fertilization (IVF) clinics in North America and Europe were randomized to start stimulation with either ELONVA 150 mcg or a daily dose of 200 IU rFSH for seven days. Patients also received rFSH (maximum 200 IU/day) from stimulation day eight onward, when required. Starting on stimulation day five, all patients received 0.25 mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation patients received by human chorionic gonadotropin (hCG). The primary endpoint was the ongoing pregnancy rate assessed at ten weeks or more after embryo transfer. In the ELONVA treatment arm the ongoing pregnancy rate (38.9 % per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH (38.1 % per started cycle).1 The number of oocytes retrieved per attempt, the co-primary endpoint, was 13.7 (± 8.2) for the ELONVA group and 12.5 (± 6.7) for the rFSH group.2

About Infertility

Infertility is a disease or condition that impairs the body's ability to perform the basic function of reproduction.3 It is often diagnosed after a couple has not conceived after one year of unprotected, well-timed intercourse.4 Women over the age of 35 are encouraged to seek diagnosis and treatment for infertility following six month of unprotected intercourse.4 Around 15% of couples of reproductive age have a fertility problem.4

There are many causes of infertility including problems with the production of sperm or eggs, with the fallopian tubes or the uterus, endometriosis, frequent miscarriage, as well as hormonal and autoimmune (antibody) disorders in both men and women.4

With infertile couples, the source of infertility lies with the male in 40% of cases and 40% with the female. The remaining 20% is either a joint problem or unknown, because the cause has not been identified. There are a variety of treatments available for infertility; these include hormone treatments, insemination and IVF, among others.4

About MSD

Today's MSD is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. MSD. Be Well. For more information, visit www.msd.com

ELONVA Minimum Product Information

ELONVA® (corifollitropin alfa) is a prescription only medicine and comes in a pre-filled syringe containing 100 µg or 150 µg of corifollitropin alfa in 0.5 mL.

ELONVA is used to help achieve pregnancy in women having infertility treatment. ELONVA causes the growth of several eggs at the same time by controlled stimulation of the ovaries. ELONVA should not be used in patients: who are allergic to corifollitropin alfa or other ingredients in ELONVA; have cancer of ovary, breast, womb or brain; are pregnant or breastfeeding; have unexpected vaginal bleeding (other than periods); have a condition called primary ovarian failure; have ovarian cysts or enlarged ovaries; have had Ovarian Hyperstimulation Syndrome (OHHS); previous controlled stimulation of the ovaries that resulted in more than 30 eggs 11mm or larger; have a basal antral follicle count higher than 20; have malformations of reproductive organs making pregnancy impossible; have fibroids that would make normal pregnancy impossible. Precautions should be taken when giving ELONVA to patients with: kidney disease; history of or an increased chance of having blood clots (thrombosis); increased risk of having multiple pregnancies (eg: twins or more). Effects on Ability to Drive and Use Machines: ELONVA may cause dizziness. Patients should be advised that if they feel dizzy, they should not drive or use machines. Common Side Effects are: Ovarian Hyperstimulation Syndrome; pelvic pain or discomfort; headache; nausea; fatigue; breast complaints.

All medicines have risks and benefits. Talk you your doctor to see if ELONVA is right for you. ELONVA is fully subsidised for patients who are eligible for government funded fertility treatment, otherwise charges will apply. A doctor’s visit fee may apply. Use only as directed and if symptoms continue or you have side effects, see your doctor.

Date of preparation: March 2012 (NZ).

For a copy of the full Consumer Medicine information leaflet please contact us at 0800 500 673 or refer to the Medsafe website at www.medsafe.govt.nz.

WOMN-1080929-0002. First Issued June 2013. TAPS CH3639

References:

1. Hammarberg K, et al. Women’s experience of IVF: a follow-up study
2. Devroey P, et al. A double-blind non-inferiority, randomized controlled trial comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod 2009; 24: 3063-72
3. Frequently Asked Questions About Infertility. American Society for Reproductive Medicine Web site. http://www.reproductivefacts.org
4. http://www.abc.net.au/health/library/stories/2007/05/30/1919840.htm#a

ENDS

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