Schering-Plough files asthma combination in Europe
This article was originally published in Scrip
The European Medicines Agency (EMEA) has agreed to review Schering-Plough's centralised EU application for approval to market a fixed-dose inhaled combination of its corticosteroid Asmanex (mometasone furoate) and the long-acting beta-2 agonist formoterol fumarate (Novartis's Foradil) for the maintenance treatment of asthma in patients aged 12 years and older.
The combination product is administered from a single metered-dose inhaler.
Schering-Plough filed the same product with the US FDA last month (scripnews.com, July 24th, 2009). It is also in Phase III development for the treatment of asthma in patients younger than 12 years and for use in chronic obstructive pulmonary disease (COPD).
The company negotiated exclusive worldwide rights to develop and commercialise a fixed-dose combination of mometasone and formoterol in May through a global collaboration with Novartis on therapies for asthma and chronic obstructive pulmonary disease (scripnews.com, May 19th, 2009).
contraceptive filed
The EMEA has also accepted a centralised marketing authorisation application from Merck Serono (Merck KGaA) for a combined oral contraceptive, nomegestrol acetate plus 17 beta-estradiol.
Schering-Plough acquired worldwide development and marketing rights to the product through its 2007 acquisition of Organon, which had licensed it from Theramex, another Merck KGaA affiliate. Theramex retains marketing and distribution rights in certain countries. Schering-Plough expects to file the product in the US next year.
The product combines the progestin nomegestrol acetate and a natural oestrogen in a monophasic dosing regimen.