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SERONO PROPOSING RESTRICTED PERGONAL INDICATION

Executive Summary

SERONO PROPOSING RESTRICTED PERGONAL INDICATION "to limit its use to women with inadequate endogenous luteinizing hormone levels, i.e., World Health Organization Group I anovulatory patients," the company said in a Sept. 20 citizen petition filed with FDA. Pergonal (menotropins) is currently indicated for "the induction of ovulation and pregnancy in the anovulatory infertile patient, in whom the cause of anovulation is functional and not due to primary ovarian failure." Menotropins is "a combination of the active ingredients follicle-stimulating hormone and luteinizing hormone," Serono said. "Serono and [FDA's] Center for Drug Evaluation & Research are discussing labeling revisions to reflect recent research, made possible by technological advances, showing that FSH is the main therapeutic agent and that the LH component of menotropins is unnecessary for the induction of ovulation and pregnancy in the majority of the patients for whom it is currently indicated." Serona's petition requests that FDA "direct [CDER] to withhold approval of any application for a combination product with both FSH and LH until the adequacy of the labeling for menotropins for the currently approved patient population has been satisfactorily resolved, unless the application contains data showing that both FSH and LH, and the combination of them, are safe and effective in all patients for which such product is indicated in the proposed labeling." Organon markets a menotropins product overseas. The company has not disclosed the status of its U.S. development of the drug. Serono said it is not aware of any pending applications for menotropins. According to IMS America, Pergonal sales for 1992 through drug stores and hospitals were about $90 mil. The total does not include sales through clinics or doctors' offices. "Menotropins was developed in the 1960s, when less was known about the pharmacology of FSH and LH in the treatment of infertility," the petition explains. "After Pergonal, Serono developed technology for separating FSH and LH, and received approval of an NDA for Metrodin, a single-entity urofollitropin product whose active ingredient is FSH." Metrodin's orphan drug exclusivity expired Sept. 18. Until the discussions between CDER and Serono are resolved, the petition maintains, "the center should not approve NDAs for products containing both FSH and LH unless they are supported by studies meeting the requirements of the combination drug policy." Whatever "may have been the case when Pergonal was originally approved, there is at this time no unanswered question about the status of menotropins as a combination of two active ingredients," Serono declared. Serono has submitted evidence to FDA that "the LH component of menotropins does not appear to enhance the effectiveness of the drug for most women," the petition states. "Moreover, the evidence suggests that the LH component may be counterproductive to the treatment objective in women with elevated endogenous LH levels. Although this evidence is not definitive, it is an additional reason why women with adequate LH should not receive exogenous LH from menotropins." Serono's recommendation to change the labeling for Pergonal "is consistent with the pharmacological principle that a patient should not be exposed to a drug without reason," the company declared. CDER "has suggested there are two reasons why narrowed indications for menotropins are not justified," the petition continues. "First, when tested as a combination, menotropins has been shown to be safe and effective in such patients. Second, not all studies have shown deleterious effects in patients whose endogenous LH levels are in the normal range." However, Serono argued, "these suggestions do not address the underlying purpose of the combination drug policy" which states that "a combination of two active ingredients is not approvable unless each ingredient is affirmatively shown to be safe and effective and unless combining them in the same dosage form is clinically justified." Serono "is aware of information that some manufacturers may supplement their menotropins product with human chorionic gonadotropin (HCG) to achieve 'LH activity' comparable to the required one-to-one ratio of FSH to LH," the petition continues. "Incorporating HCG in a menotropins-like product...further invokes the combination drug policy," Serono maintained.
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