US FDA approves Glaxo/Theravance drug for COPD lung disease

Posted: Published on May 11th, 2013

This post was added by Dr P. Richardson

* Theravance (NasdaqGS: THRX - news) shares up 11 percent

* Drug to carry warning against use in asthma

* Drug will compete with AstraZeneca (NYSE: AZN - news) 's Symbicort (Updates with FDA comment, side effects)

By Toni Clarke

May 10 (Reuters) - The U.S. Food and Drug Administration has approved a new drug to treat chronic obstructive pulmonary disease, a condition often associated with smoking that can include emphysema, chronic bronchitis, or both.

The drug, Breo, is an inhaled treatment made by British drugmaker GlaxoSmithKline Plc (Other OTC: GLAXF - news) and Theravance Inc of the United States. It consists of a corticosteroid, fluticasone furoate, which reduces inflammation, and a novel long-acting beta-agonist, called vilanterol, which is designed to open the airways. The product is inhaled through a palm-sized device called Ellipta.

COPD is the third-leading cause of death in the United States, according to federal data.

Theravance shares were up 11 percent to $34.78 in afternoon trading. Glaxo's U.S. shares rose 1.95 percent to $51.69.

Breo, or Relvar as it would be called if approved outside the United States, will compete with GlaxoSmithKline's twice-daily asthma and COPD drug Advair, a roughly $8 billion-a-year drug that contains the steroid fluticasone propionate and the long-acting beta-agonist salmeterol.

Analysts on average expect the drug to generate annual sales of $559 million by 2015, according to Thomson Reuters data.

See more here:
US FDA approves Glaxo/Theravance drug for COPD lung disease

Related Posts
This entry was posted in Drug Side Effects. Bookmark the permalink.

Comments are closed.