Theravance Biopharma‘s (NSDQ:TBPH) said today that the FDA granted expanded indications for GlaxoSmithKline‘s (NYSE:GSK) Trelegy Ellipta inhaler, now approved for use to treat a broader population of chronic obstructive pulmonary disease patients.
With the expansion, the inhaler is now cleared for COPD patients with airflow limitations and for those who have experienced an acute worsening of respiratory symptoms, the Dublin-based company said. The system is intended as a long-term, once-daily maintenance to treat airflow obstructions, as well as to reduce exacerbations of COPD.
Theravance said it has an interest in the Trelegy Ellipta because it is entitled to receive an 85% economic interest in roylaties paid by GSK on worldwide net sales, which it said are upward-tiering from 6.5% to 10%. Theravance said it expects resulting cash flows of approsimatly 5.5% to 8.5% for worldwide sales of the inhaler, according to a press release.
In January, Theravance Biopharma announced that the FDA accepted its marketing application for revefenacin, an inhaled long-acting muscarinic antagonist designed to treat chronic obstructive pulmonary disease.