Alvesco has been approved by the FDA for the maintenance treatment of asthma and as prophylactic therapy in patients over the age of 12, according to the manufacturer Nycomed.
Alvesco is an inhaled corticosteroid, which inhibits the activity of pro-inflammatory cells and promotes the endogenous production of anti-inflammatory substances. Alvesco has been approved in 45 countries and introduced in 30, with more launches expected this year.
The decision of the FDA allows the product to be sold in the largest pharmaceutical market in the world, where it is patent protected until 2017. Nycomed is in active negotiations with possible marketing partners for the commercialization of Alvesco in the United States. The outlicensing strategy in the U.S. is consistent with Nycomed’s direction to seek marketing and commercialization partnerships for the Nycomed’s assets in the US market.
“The approval of Alvesco provides a new and effective treatment option to help patients control their asthma and improve their quality of life, and will be an important treatment option for physicians,” said Myron Zitt, MD, chief of allergy and immunology at the Queens Long Island Medical Group in Babylon, NY, and clinical associate professor of medicine at the State University of New York, Stony Brook, School of Medicine.
“We are very much looking forward to serving patients in the United States with this innovative drug and build upon the experience we already have gained with Alvesco. This approval certainly adds to the respiratory area, which is a key segment for Nycomed to grow”, comments Dick Soderberg, Executive Vice President of International Marketing.