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SkyePharma PLC's BREO ELLIPTA Receives Regulatory Approval in US

Monday, 13 May 2013 02:01am EDT 

SkyePharma PLC (Skyepharma) announced that the United States Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for BREO ELLIPTA, a combination product submitted by GlaxoSmithKline (GSK), for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved for the reduction of COPD exacerbations in patients with a history of exacerbations. BREO ELLIPTA is not indicated for the relief of acute bronchospasm or for the treatment of asthma. BREO ELLIPTA (fluticasone furoate/vilanterol 100/25 mcg) incorporates one of the Group's dry powder formulation technologies for inhalation products licensed to GSK. GSK has stated that it anticipates that BREO ELLIPTA will be available in the United States during the third quarter of 2013. This medicine is not approved or licensed in the European Union or anywhere outside of the U.S. Skyepharma is entitled to a low single digit royalty on net sales of products using the licensed technology, capped at a maximum amount of £3.0 million per annum for each chemical entity for the life of the relevant patents. The Prescription Drug User Fee Act (PDUFA) target date of the application for ANORO ELLIPTA (for COPD) by the FDA in the United States is 18 December 2013. The product was also filed for approval in Europe and Japan in January and April 2013 respectively. 

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