The US Food and Drug
Administration (FDA) has granted Serono, Inc. marketing approval for
Ovidrel® (choriogonadotropin alfa for injection) for use in infertility
treatment, making it the first recombinant human chorionic gonadotropin (hCG)
to be approved in the world.
It is the first new recombinant molecule to receive marketing
authorization for the treatment of infertility since the approval of
recombinant follicle stimulating hormone in 1995 with the approval of Serono's
Gonal-F® (follitropin alfa for injection) by the European Agency for the
Evaluation of Medicinal Products (EMEA). Serono is planning to launch
Ovidrel® in the US by the first quarter of 2001. The company hopes to
receive marketing approval from the EMEA for Ovidrel® in the first half of
Approximately one in ten couples of reproductive age experiences
infertility. The most common cause of infertility in women is anovulation,
which is brought about by irregularities in the hormones needed to produce and
release healthy eggs. Ovidrel® is administered after the stimulation of the
growth of follicles or eggs in the ovaries of women being treated for
infertility. Ovidrel® is used to trigger ovulation in women with
infertility due to anovulation and to promote final maturation of eggs in the
ovaries of women undergoing assisted reproductive technologies (ART), such as
Easy Subcutaneous Administration, Safety and Effectiveness
Ovidrel® is the only hCG in the US to be approved for subcutaneous
injection (with a small needle under the skin), making administration
convenient. Until now, hCG was extracted from the urine of pregnant women.
Urine-derived hCG must be injected intramuscularly, which can often be painful
and usually requires the assistance of a partner or healthcare provider.
Clinical studies have shown that Ovidrel® is safe and effective. In
comparative trials versus an approved urine-derived hCG, Ovidrel® was
associated with a lower incidence of injection site disorders, as described in
the full prescribing information. Furthermore, because it is produced by
recombinant DNA technology, Ovidrel® has a high level of purity that permits
the use of more accurate and precise assays to measure product strength than
is possible with urine-derived products.
Serono's Patient-Friendly Fertility Products
"The approval of Ovidrel® by the FDA represents a major milestone in the
development of treatments for infertility," said Mike Allen, Executive Vice
President, North America, Reproductive Health. "Ovidrel® is a convenient
alternative to urine-derived hCGs and enhances the patient-friendly portfolio
of infertility products offered by Serono."
Serono's other reproductive health products include Gonal-F®
(follitropin alfa for injection), which is subcutaneously administered for
ovarian stimulation; Ovidrel®, which is subcutaneously administered to
trigger ovulation; and a non-injectable form of progesterone therapy,
Crinone® (progesterone gel), which is administered for luteal phase support.
Side effects may occur with the use of fertility drugs. These products
should only be prescribed by physicians who are thoroughly familiar with
infertility problems and their management. Ovarian hyperstimulation syndrome
(OHSS), with or without vascular and pulmonary complications, can occur with
the use of fertility drugs. The incidence of uncomplicated, non-severe OHSS
in patients using Ovidrel® was 1.7% in ART and 3.0% in ovulation induction.
Other side effects in women using Ovidrel® include abdominal pain, injection
site reactions, nausea and vomiting. Side effects in women using Gonal-F®
include headache, nausea, ovarian cysts and upper respiratory tract infection.
Side effects for patients using Crinone® include breast enlargement,
constipation, cramps, emotional lability, headache, nausea and somnolence.