EU regulators accept Novartis’ triple asthma combo

European regulators have accepted Novartis’ filing for a triple combination therapy for asthma known as QVM149, triggering payments to development partners Vectura and Sosei.

QVM149 is a triple therapy consisting of indacaterol (acetate), glycopyrronium (bromide) and mometasone (furoate), which is being developed as a daily inhaled treatment for asthma delivered via the company’s Breezhaler inhaler.

Novartis is trying to develop a drug that will outperform GlaxoSmithKline’s Seretide/Advair twice-daily inhaler and generics, while also offering patients protection from asthma episodes with a single daily dose.

GSK is also developing its rival Trelegy three-in-one inhaler for asthma after getting it approved first in chronic obstructive pulmonary disease (COPD).

Novartis’ new therapy combines the long-acting LABA drug indacaterol and muscarinic agonist glycopyrronium that are the active ingredients in Novartis’ Ultibro Breezhaler, and adds the inhaled steroid mometasone, and is designed as a daily preventive therapy.

Under a respiratory drug agreement dating back more than a decade, Sosei and its UK subsidiary Heptares will receive a $2.5 million payment from Novartis, and Vectura will also receive the same amount.

Both companies are also set to receive further payments of $5 million should European regulators decide to approve the combination.

The Swiss pharma earlier this week announced results from two phase 2 studies involving QVM149, one showing the drug improved lung function over one second in asthma compared with GSK’s twice daily standard-of-care Advair/Seretide (salmeterol+fluticasone), and another showing an improvement compared with placebo.

Both high and medium doses also met a further study goal with an improved “area under the curve” readout compared with Advair/Seretide, showing an overall improved performance over the time period measured.

Novartis noted safety data showing adverse events observed were comparable with placebo.

QVM149 is currently being investigated in Phase III/IIIb studies IRIDIUM and ARGON in asthma, which are expected to complete in the third quarter of this year.

Shinichi Tamura, chairman, president and CEO of Sosei Heptares, said: “With the filing of the MAA for approval in Europe, we are greatly looking forward to seeing QVM149 become available to patients and improve the lives of those with uncontrolled asthma.”

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