Novartis’ Ultibro Breezhaler has become the first dual action bronchodilator to be approved in the EU for chronic obstructive pulmonary disease (COPD).
Ultibro (formerly QVA149) combines the long-acting muscarinic antagonist (LAMA) glycopyrronium bromide with the long-acting beta agonist (LABA) indacaterol, which are already approved as monotherapies in the EU as Seebri and Onbrez, respectively.
EU approval means that Novartis has pipped arch-rival GlaxoSmithKline to the post in securing approval for the first LABA/LAMA combination in the EU, with the latter’s Anoro (vilanterol and umeclidinium bromide) candidate still under regulatory review after being filed for approval in May.
The product is already marketed as Xoterna in some countries, and was recently given a green light as Ultibro in Japan.
“Many COPD patients will now have a better treatment option, including first-line therapy with the launch of Ultibro Breezhaler in Europe,” commented David Epstein, division head of Novartis Pharmaceuticals.
The approvals in both Europe and Japan were based on data from the large-scale IGNITE trials programme, which spanned 11 studies involving more than 10,000 patients with COPD.
The trials showed that Novartis’ combination therapy was more effective on a range of measures – including breathlessness, rescue medication use and quality of life scores – than placebo and Pfizer/Boehringer Ingelheim’s blockbuster COPD product Spiriva (tiotropium).
The roll-out of LAMA/LABA combinations is expected to herald a new growth spurt in the market for COPD therapies, with Citigroup predicting the new products will help the market expand from $10bn this year to $14bn in 2018.
GSK took a major step closer to brining Anoro to market in the US earlier this month when an FDA advisory committee voted in favour of approval for COPD.
Novartis has not yet filed for approval of Ultibro in the US), while AstraZeneca, Boehringer/Pfizer and Forest Labs/Almirall are all bringing their own LAMA/LABA combinations through the pipeline.
That competitive landscape means however that while getting bigger, individual products in the COPD market are unlikely to reach the highs of the current stable, such as GSK’s $7.6bn Advair (salmeterol and fluticasone) and AstraZeneca’s $3bn Symbicort (formoterol and budesonide).
New draft FDA guidance promises to make it easier for generic companies to introduced copies of combination respiratory drugs will also shake up the market in the coming years.