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FDA Grants Marketing Approval For Ovidrel (Choriogonadotropin Alfa) For Infertility Treatment
GENEVA, SWITZERLAND and NORWELL, MA -- Oct. 2, 2000 -- 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 2001.
Approximately one in 10 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 in-vitro fertilization.
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.
"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 reproductive health product portfolio includes 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.
Serono's vision is to develop innovative products to assist patients at every stage of the reproductive cycle, from ovulation to early pregnancy. The development of Ovidrel takes the company one step closer to realizing that vision and to being the first company providing a totally recombinant gonadotropin portfolio.
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 percent in ART and 3.0 percent 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.
For more information and Ordering call:
Franklin Drug Center
Call Toll Free: 800-537-3788
Fax: 800-537-8044
Съдбата води желаещия, нежелаещия влачи!Редактирано от mery_ на 16.05.02 07:36.
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