With EMA review in progress, Novartis unveils more positive data on asthma therapy
Having made its marketing pitch to the EU regulator, Novartis on Thursday unveiled positive pivotal study data supporting the use of its inhaled asthma treatment.
The therapy, QMF149, consists of the long-acting beta-agonist, or LABA, called indacaterol acetate and the corticosteroid mometasone furoate. In the 2,216-patient, 52-week PALLADIUM study, asthma patients either received a medium or high dose of the Novartis therapy (150/160 μg; 150/320 μg) or mometasone furoate (MF) alone.
Data showed both doses of QMF149 induced a statistically superior improvement over mometasone furoate (MF) alone in terms of lung function measured via Forced Expiratory Volume in one second (FEV1) at week 26 — meeting the main goal of the study. The Novartis therapy was also superior to MF in controlling asthma, a key secondary endpoint, measured via responses from patients in the Asthma Control Questionnaire, the company said, adding that the results were also observed at week 52.
Novartis has another once-daily inhaled asthma therapy in its arsenal — QVM149, which consists of the ingredients in QMF149 as well as glycopyrronium bromide, a long-acting muscarinic receptor antagonist (LAMA). Both therapies have been submitted to the EMA for review for use in patients with uncontrolled asthma, where symptoms persist and exacerbations are frequent despite therapy.
Novartis chief Vas Narasimhan has tapped QVM149 as one of the Swiss drugmaker’s key drugs that has the potential to reap blockbuster sales after the therapy bested GlaxoSmithKline’s key bestseller Advair in a mid-stage study. Advair, which is considered the current standard of care, consists of a LABA and a steroid.
In September, Novartis unveiled some results from the IRIDIUM study — which compared QVM149 to QMF149 in addition to Advair. It also teased the results from the PALLADIUM study. In May, the Swiss drugmaker also disclosed data from the QUARTZ study, that tested QMF149 against a corticosteroid monotherapy.
European approvals for both therapies is expected in the first half of next year, Jefferies analysts wrote in an October note, predicting $400 million in combined peak sales in ex-US geographies.