The FDA announced Wednesday the approval of GlaxoSmithKline and Theravance's Anoro Ellipta (umeclidinium/vilanterol) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). The companies said the drug is the first once-daily product approved in the US that combines two long-acting bronchodilators in a single inhaler for the maintenance treatment of COPD.
The therapy, which will carry a boxed warning concerning the increased risk of asthma-related death related to LABAs, combines the long-acting muscarinic antagonist (LAMA) umeclidinium with the long-acting beta-adrenergic (LABA) agonist vilanterol delivered via the Ellipta dry powder inhaler. Further, the Phase III programme for Anoro Ellipta included seven clinical studies with nearly 6 000 patients with COPD.
The decision from the FDA follows a positive recommendation by an FDA advisory committee in September, although the panel suggested that the companies performed post-marketing studies of the therapy in patients with more severe COPD. In documents released ahead of the advisory panel meeting, FDA staff said that Anoro Ellipta is effective but questioned the drug's safety profile, especially its cardiovascular safety.
Under the terms of a 2002 agreement, GlaxoSmithKline will receive a milestone payment of $30 million from Theravance for the approval of Anoro Ellipta and a second payment of $30 million upon the therapy's launch, which is anticipated in the first quarter of 2014. Meanwhile, GlaxoSmithKline will pay Theravance tiered royalties of 6.5 percent to 10 percent on sales of the therapy. Analysts project that the drug will generate sales of $1.2 billion in 2016 and about $2.7 billion by 2018.
GlaxoSmithKline and Theravance submitted Anoro Ellipta for approval in Europe in January. Meanwhile, Novartis' LAMA/LABA combination therapy for COPD Ultibro Breezhaler (indacaterol/glycopyrronium) was cleared by European regulators in September. AstraZeneca and Boehringer Ingelheim, as well as Forest Laboratories and Almirall, also have LAMA/LABA combination products for COPD under development.
For related analysis, read ViewPoints: Witty paints rosy picture for GlaxoSmithKline's respiratory franchise.
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