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FDA panel backs GSK's asthma drug Breo for adults only

Already approved to treat COPD in the US

GSK - logo on building 

GlaxoSmithKline and Theravance's Breo has been recommended for approval by an FDA advisory committee for asthma, but only in adults.

Breo is already approved to treat chronic obstructive pulmonary disease (COPD) in the US but use in asthma has been held up by regulatory caution - dating back to 2010 - about the safety of long-acting beta agonists (LABAs) in children.

The product is sold as Relvar in some markets and is a follow-up to GSK's blockbuster Seretide/Advair product and combines LABA vilanterol with the inhaled corticosteroid (ICS) fluticasone furoate.

The FDA's panel of experts said the safety and efficacy data for Breo support its use as an asthma treatment in patients aged 18 or over, but voted almost unanimously against giving a green light in those aged 12 to 17.

The advisors have also recommended that GSK conduct a large-scale post-marketing safety study in both adults and adolescents as a condition of approval. The FDA is due to deliver a verdict on the marketing application by 30 April, and while it is not required to follow the advice of its panels generally does so.

GSK will be hoping that approval in asthma - even if only in adults - will give a boost to sales of Breo, which has got off to a fairly slow start in the market, with sales of $111m last year, well shy of Advair's $8bn-a-year peak.

Breo is one of a stable of new drugs that GSK is banking on to help defend its respiratory franchise, which came under serious pressure last year - particularly in the US - largely because of pricing and competitive pressure on Advair which lost a quarter of its turnover

While Breo is a like-for-like follow-up to Advair GSK is also hoping for big things from Anoro, which combines vilanterol with long-acting muscarinic antagonist (LAMA) umeclidinium bromide, which posted sales of $27m in 2014. 

A month ago, Theravance chief executive Mike Aguiar said that both Breo and Anoro are building up momentum in the US, with week-on-week increases in prescribing levels of around 10%, outpacing background growth in the market.

Breo could also see a boost from the results of the 16,000-patient SUMMIT mortality study in COPD patients who also have cardiovascular disease (CVD) or are at heightened risk for CVD.

"Should the study prove to be positive, it could be a significant differentiating feature compared to other LABA/ICS products and support the use of Breo in this patient population," said Aguiar, who also pointed to an ongoing real-world evidence (RWE) study of Breo in COPD which should generate data in 2016.

Article by
Phil Taylor

20th March 2015

From: Sales



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