Date of FDA Decision
(PDUFA):
|
December 18, 2013
|
Company name(s):
|
Theravance and
GlaxoSmithKline
|
Brand Name:
|
Anoro Ellipta
|
Generic Name:
|
umeclidinium bromide +
vilanterol
|
Type of application:
|
First NDA Submission;
combination of previously unapproved bronchodilator umeclidinium bromide + vilanterol,
previously approved as part of other Ellipta drugs + Ellipta mixing
technology previously approved as part other Ellipta drugs
|
Indication:
|
Chronic Obstructive
Pulmonary Disease (COPD)
|
Advisory Committee
(AdCom) History:
|
On Sept 10, 2013, FDA Pulmonary-Allergy
Drugs Advisory Committee (PADAC) voted 11 yes to 2 no that the efficacy and
safety data provide substantial evidence to support approval of Anoro
Ellipta
|
Following up from their previous
joint COPD development Breo Ellipta, which was approved in May 2013, Theravance
and GSK have now submitted an application for another combination therapy –
Anoro Ellipta, which features umeclidinium bromide (GSK) and vilanterol (Theravance)
- a long-acting muscarinic antagonist (LAMA) and a long-acting adrenergic
receptor beta 2 agonist (LABA) in 62.5/25mcg and 125/25mcg doses. The Anoro
Ellipta technology features a dual-compound Ellipta inhaler device, which only
allows for compound mixing at the point of entry.
COPD is the fourth leading cause
of death in the US. The global COPD market was worth US$ 10.59 billion in 2010.
Although the market needs are sufficiently met with a multitude of drugs (COPD
leaders are Advair, Arcapta, Daliresp, etc), Theravance and GSK can contend for
a meaningful portion of the market due to an apparently lower number of side
effects in comparison with Anoro Ellipta’s competitors.
On September 10, 2013, FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 11 yes to 2 no that the efficacy and safety data provide substantial evidence to support approval of Anoro Ellipta, probably paving the wave for a positive approval on the 18th.
Umeclidinium bromide(GSK573719A) is a muscarinic receptor antagonist which is useful in treatment of chronic obstructive pulmonary disease (COPD). Umeclidinium bromide
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