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2019-10-04| R&DTrials & Approvals

Novartis Reports Trial Successes of its Asthma Drugs that Holds Potential Edge Over Longstanding Market Leader

by Rajaneesh K. Gopinath
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By Rajaneesh K. Gopinath, Ph.D.

The Swiss drug maker announced positive results from studies belonging to its PLATINUM Clinical Development Program that tested two inhalable asthma drug candidates. The drugs demonstrated improvement in lung function in patients who remained uncontrolled following the standard combination therapy of long-acting beta agonist and inhaled corticosteroid.

In what could be considered a double win, Novartis simultaneously announced the study results of its two-phase III trials, PALLADIUM and IRIDIUM evaluating the inhaled combinations of QVM149 and QMF149. Approval of the drugs could prove to be a major breakthrough in the field and could potentially dethrone GSK’s Advair for the treatment of asthma.

In both studies, the primary endpoint was the improvement in trough forced expiratory volume in one second (FEV1) after 26 weeks. In the PALLADIUM study, QMF149 (indacaterol acetate and mometasone furoate) met the primary endpoint by demonstrating superior improvement in lung function versus mometasone furoate. It also met the secondary endpoint, which is the improvement in the Asthma Control Questionnaire (ACQ-7) score.

On the other hand, the IRIDIUMstudy revealed that QVM149 (indacaterol acetate, glycopyrronium bromide and mometasone furoate) demonstrated a statistically significant improvement in lung function versus QMF149. While the key secondary endpoint of improvement of ACQ-7 score was not met in the IRIDIUM study, a substantial reduction was observed in severe asthma exacerbation rates with QVM149. The improvements in both studies were observed in asthma patients who remained uncontrolled following standard treatments such as inhaled corticosteroid (ICS) at medium or high dose, or low doses of Advair which is a combination of long-acting beta agonist (LABA) and ICS. Both the candidates were administered using the dose-confirming Breezhaler® device.

“Despite being on treatment with LABA/ICS, nearly half of all patients with moderate-to-severe asthma are uncontrolled and at a higher risk of exacerbations, hospitalization or even death,” said Dr. Huib Kerstjens, University Medical Center Groningen, The Netherlands. “For these patients, it is important to explore additional options to improve treatment outcomes and quality of life. The initial results of IRIDIUM show us that QVM149 can improve lung function in these patients and potentially deliver substantial reduction in exacerbation rates, which can have a significant impact on the daily lives of people with uncontrolled asthma.” Recently, Novartis’ Global Drug Development (GDD) team provided an insight into their pipeline and QVM149 was touted to be one of the 25 potential blockbusters from the company.

It is also notable that Novartis is currently evaluating another Asthma drug Fevipiprant (QAW039), an orally available antagonist of the prostaglandin D2 receptor 2. All in all, it’s an exciting year for the asthma community to look forward to.

 

References
  1. https://www.novartis.com/news/media-releases/novartis-announces-positive-results-from-phase-iii-palladium-study-inhaled-combination-qmf149-patients-uncontrolled-asthma
  2. https://www.novartis.com/news/media-releases/novartis-announces-positive-results-from-phase-iii-iridium-study-inhaled-combination-qvm149-patients-uncontrolled-asthma
  3. https://www.novartis.com/news/media-releases/novartis-highlights-company-transformation-catalyst-rich-pipeline-and-strong-progress-strategy-meet-novartis-management-investor-event

 

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