Schering-PloughCorporation has announced that the European Medicines Agency(EMEA) has validated (accepted for review) the company’s MarketingAuthorization Application (MAA) for a fixed-dose combination of mometasonefuroate and formoterol fumarate for the maintenance treatment of asthma inpatients 12 years of age and older. The company also announced today that theEMEA has validated the MAA for nomegestrol acetate (2.5 mg) / 17beta-estradiol (1.5mg), a combined oral contraceptive (COC) containing aunique combination of a natural estrogen identical to the estrogen produced bya woman’s own body and a selective progestin. Mometasone furoate/formoterol fumarate combines mometasone furoate, theactive ingredient of the inhaled corticosteroid, ASMANEX , with formoterolfumarate, the active ingredient of the long-acting beta2-agonist, FORADIL ,administered via a single metered-dose inhaler. Marketing approval from the EMEA is being sought for nomegestrolacetate/17 beta-estradiol as an oral treatment for women to prevent pregnancy.Both applications will follow the Centralized Procedure. “These two regulatory milestones are important steps toward advancing ourlate-stage pipeline and meeting patient needs. If approved by the EMEA, themometasone furoate/formoterol fumarate combination would represent animportant additional treatment option for physicians and their patients andfurther strengthen Schering-Plough’s portfolio of respiratory products,” saidThomas P. Koestler, Ph.D., executive vice president and president,Schering-Plough Research Institute. “Schering-Plough is also committed toproviding women a variety of birth control options to meet diverse lifestyleneeds and choices.”
