Advisors to the US regulator have voted to recommend approval of Novartis' chronic obstructive pulmonary disease drug indacaterol but only at the lower of the two doses proposed by the Swiss drugmaker.
The Pulmonary-Allergy Drug Advisory Committee of the US Food and Drug Administration has backed QAB149 (indacaterol) 75 mcg as a once-daily long-term maintenance bronchodilator treatment in patients with COPD, including chronic bronchitis and/or emphysema. The panel voted 13 to four in favour of that dose, but 12 to five against recommending approval of 150 mcg of indacaterol, a long-acting beta2-agonist (LABA).
The PADAC noted that 75 mcg was seen as effective as the 150 mcg dose and the committee endorsed the safety of both doses. In October 2009, the FDA issued Novartis with a complete response letter for indacaterol and specifically requested additional information on the dosing.
The treatment is already approved in Europe under the tradename Onbrez Breezhaler at 150 and 300 mcg once-daily doses and brought in revenues of $33 million in 2010. If approved in the USA, it will be sold as Arcapta Neohaler.
Analysts believe that indacaterol as a monotherapy will only have modest sales but will be lucrative as part of a combo. Jacoba van der Gaag at Datamonitor says that an approval would pave the way for Novartis’ new respiratory franchise, which includes two once-daily combinations using indacaterol; QMF149 with the inhaled corticosteroid mometasone and QVA149 with the long-acting muscarinic antagonist glycopyrrolate.
She expects QVA149 to launch in 2013, followed by QMF149 two years later, and Novartis’ indacaterol-containing products to reach $2.4 billion in the seven major markets by 2019, with the majority of sales coming from combos. GlaxoSmithKline’s rival once-daily LABA, GSK642444, is currently in Phase III and a filing is expected later this year but Ms van der Gaag lnotes that COPD patients "have high brand loyalty stemming from hesitation to switch between devices [and] this positive vote for Novartis increases the company’s chances of establishing its brands early, and benefiting from a first mover advantage".