GlaxoSmithKline (GSK) and partner Theravance moved closer to getting US approval for their chronic obstructive pulmonary disease (COPD) drug Breo yesterday after an FDA panel vote went their way.
The advisory committee voted by to 9 to 4 that GSK and Theravance's data supported the use of Breo (fluticasone furoate plus vilanterol) as a once-daily maintenance treatment for COPD. Panellists also concluded - by the same margin - that the drug was effective in reducing exacerbations in COPD.
The final decision now rests with the FDA, which is due to deliver a verdict on the application by May 12, 2013.
Shares in GSK rallied ahead of the advisory committee meeting after the agency's reviewer published documents that took a pragmatic view of Breo's safety data, particularly with regard to pneumonia-related deaths seen in trials of the combination versus vilanterol alone. Concern about that data seemed to be the main reason for the 'no' votes at the panel meeting.
Breo, delivered once-daily using a new Ellipta inhaler, is seen as a critical drug for GSK as it tries to defend its asthma and COPD franchise dominated by twice-daily Advair/Seretide (fluticasone and salmeterol), which had sales of around £5bn ($7.6bn) last year.
While Advair has already lost patent protection in some markets, it has proved resistant to generic competition – in part because of its relatively sophisticated Diskus inhaler device and also because of higher regulatory hurdles for new asthma drugs.
Breo Ellipta (which will be sold as Relvar in Europe) is being positioned by GSK alongside other new COPD drugs in its Advair replacement programme, notably Anoro – a combination product based on vilanterol and long-acting muscarinic antagonist umeclidinium bromide that has already been submitted for approval in the US and EU.
Analysts have said that despite the likely lack of a surge in generic competition to Advair in the coming quarters, Breo will help GSK offset downward pricing pressure in the COPD market.
These include new market entrants, generics of AstraZeneca's Symbicort (budesonide/formoterol) which are already on the market, as well as patent expirations for Boehringer Ingelheim/Pfizer's big-selling COPD product Spiriva (tiotropium), which begin in 2014.
Savvas Neophytou of analysts Panmure Gordon predicted a late 2013 launch for Breo, and said sales could reach £500m in 2015. Meanwhile, Cowen & Co said the drug could make up to $2bn in 2018.
Other COPD combinations coming through development include Boehringer Ingelheim/Pfizer's olodaterol/tiotropium, Novartis' QVA149 (glycopyrronium bromide and indacaterol maleate) and Forest Labs/Almirall's aclidinium bromide/formoterol candidate, which are all in phase III.