Status: recently approved in European Union

Organizations involved:

Merck Serono S.A. – Manuf.; R&D; Tech.; Intl. mark.

EMD Serono, Inc. – USA mark.

Merck KGaA – Parent

Serono International S.A. – Former

Cross ref.: See the entries for the components of this combination product --Gonal-f (#156) and Luveris (#228).

Description: Pergoveris refers to aqueous and lyophilized (freeze-dried) formulations combining recombinant Chinese hamster ovary cell (CHO)-expressed human FSH (follitropin alfa 150IU), marketed as Gonal-f, and recombinant CHO-expressed human LH (r-hLH or lutropin alfa 75IU), which allows administration of both substances in a single subcutaneous injection. [With the product just approved as this edition was being finalized, further information, e.g., EMEA EPAR documents and product inserts/labeling, were not yet available].

Pergoveris is the only infertility treatment to offer the benefits of recombinant FSH and LH in a single injection (administered subcutaneously)

Nomenclature; FSH plus LH, rDNA/Serono [BIO]; Pergoveris [TR]; follicle stimulating hormone alpha plus luteinizing hormone, recombinant [SY]; FSH plus LH, rDNA [SY]; LH plus FSH, rDNA [SY]; luteinizing hormone plus follicle stimulating hormone alpha, recombinant [SY]

Companies.: The components of Pergovis, Gonal-f and Luveris, and Pergovis were developed by Serono International S.A. In Jan. 2007, Merck KGaA acquired Serono, which was renamed Merck Serono S.A.

Status: Pergovis received European Union (EU) approval on June 27, 2007, with this likely including orphan designation.

Indications: [in EU] = stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/L.