GlaxoSmithKline received federal approval for its Breo Ellipta inhaler for use in patients with chronic obstructive pulmonary disorder. A warning notes the therapy is not approved for use to treat asthma.
GlaxoSmithKline and Theravance submitted a supplemental new drug application to the FDA for approval to use its chronic obstructive pulmonary disease inhaler Breo Ellipta, a combination of fluticasone furoate and vilanterol, in asthma patients 12 and older.
GlaxoSmithkline and Theravance obtained the FDA's approval to market their inhaled drug Anoro Ellipta, a combination of vilanterol and umeclidinium, as a once-daily treatment for chronic obstructive pulmonary disease.
Theravance and GlaxoSmithKline received approval in Europe to market Relvar, a combination of corticosteroid and a long-acting beta-agonist, as a treatment for both chronic obstructive pulmonary disease and asthma. The approval gives GSK the right to collect a $15 million milestone fee from Theravance and another $15 million when the drug is commercialized.
GlaxoSmithKline and Theravance obtained FDA approval to market Breo, a combination of the new beta agonist vilanterol and fluticasone furoate, a corticosteroid, as a treatment for chronic obstructive pulmonary disease. Due to risk of asthma-related death, the inhaled treatment will carry a boxed warning.
An FDA panel recommended approval of GlaxoSmithKline and Theravance's Breo Ellipta dry powder inhaler to address chronic obstructive pulmonary disease. The agency could decide on the drug's approval by May 12.