Summary GlaxoSmithKline are also working to develop such LABA/LAMA combination.
LONDON (Reuters) - Swiss drugmaker Novartis won an important endorsement of its new inhaled medicine for chronic lung disease on Friday when European regulators recommended approval of Ultibro Breezhaler.
Also known as QVA149, the once-daily medicine belongs to a new type of dual-action treatments that are expected by analysts to become major sellers and is the first in the class to win such a green light.
The green light from the European Medicines Agency (EMA) paves the way for full marketing authorization in the next two or three months. Approval in the key U.S. market remains some way off, since the drug will not be filed there until late 2014.
The new product contains two bronchodilators - indacaterol, a long-acting beta2-adrenergic agonist (LABA), and glycopyrronium, a long-acting muscarinic antagonist (LAMA).
Glycopyrronium was licensed from Vectura, entitling the British firm to milestone payments and royalties on sales. Shares in Ventura rose 7 percent on Friday s news.
Other companies including GlaxoSmithKline are also working to develop such LABA/LAMA combinations.
Novartis is banking on new drugs, including QVA149, to fill the gap left by the loss of exclusivity on its blockbuster blood pressure pill Diovan. It also has high hopes for Serelaxin, a treatment for acute heart failure and psoriasis drug AIN457.
QVA149 is designed to treat chronic obstructive pulmonary disease (COPD), a disease that causes breathing trouble and chronic coughing, and is sometimes fatal. It affects an estimated 210 million people worldwide.
Analysts at Berenberg said Ultibro could achieve annual sales of around $2.3 billion by 2021, of which $1.7 billion could be generated outside the United States.
