Hopes that Novartis' chronic obstructive pulmonary disease drug indacaterol would be approved shortly across the Atlantic have been dashed after the US regulator said it needs more time to complete its review.
The US Food and Drug Administration has extended the regulatory review period for indacaterol, also known as QAB149, by three months. The agency says it needs more time to examine data submitted by the Swiss major for the once-daily treatment and this means that a decision is now unlikely before July.
However the agency has not requested additional data on indacaterol. Head of development at Novartis Pharma, Trevor Mundel, noted that the three-month extension "reflects discussion at the advisory committee based on the comprehensive clinical programme resulting in a large amount of data to be reviewed".
A fortnight ago, the FDA's Pulmonary-Allergy Drug Advisory Committee backed indacaterol 75 mcg, voting 13 to four in favour of that dose. However, the panel voted 12 to five against recommending approval of 150 mcg of the drug, which is a long-acting beta2-agonist.
Analysts believe indacaterol as a monotherapy will only have modest sales but will be lucrative as part of combination treatment currently being evaluated, ie with the inhaled corticosteroid mometasone and also with the long-acting muscarinic antagonist glycopyrrolate.
The treatment is already approved in Europe under the tradename Onbrez Breezhaler at 150 and 300 mcg once-daily doses. If approved in the USA, it will be sold as Arcapta Neohaler.