As anticipated, GlaxoSmithKline has filed its experimental chronic obstructive pulmonary disease (COPD) drug umeclidinium bromide in the US, hot on the heels of a filing in Europe just days ago.
The UK drug giant is seeking permission to market its product as a long-term, once-daily, maintenance bronchodilator for the treatment of airflow obstruction in patients with the condition, including chronic bronchitis and emphysema.
Umeclidinium bromide (formerly known as GSK573719) is a long-acting muscarinic antagonist (LAMA) delivered via the Ellipta inhaler.
The 62.5 mcg dose filed refers to that contained inside the inhaler, which is equivalent to the 55 mcg delivered dose (emitted from the inhaler) that was submitted for approval in Europe.
Further regulatory filings are planned in other countries during the course of year, the drugmaker said.
Umeclidinium bromide is one of several late-stage assets housed in GSK’s respiratory development portfolio. Just a few weeks ago, advisors to the US Food and Drug Administration recommended approval of its COPD inhaler Breo Ellipta, which is partnered with Theravance.
COPD is the third leading cause of death in the US and is thought to affect around 24 million people in the country alone.
Back in 2010, it was estimated that COPD cost the US economy (both directly and indirectly) around $50 billion, highlighting the need for more treatment options for the condition.
