Novartis chalks up another phase 3 asthma win as approval nears

A phase 3 trial of Novartis’ QMF149 in patients with uncontrolled asthma has met its primary endpoint. Novartis showed the drug combination is better at improving lung function than an inhaled corticosteroid (ICS) alone, giving it a boost as it heads toward an approval decision in the EU.

QMF149 features an ICS, mometasone furoate, plus a long-acting beta agonist (LABA), indacaterol acetate. The idea of combining an ICS and LABA is well established. GlaxoSmithKline’s Advair and Breo, AstraZeneca’s Symbicort and Merck’s Dulera all contain an ICS and a LABA. And, in some cases, have been around long enough that they now face generic competition.

The phase 3 results shared by Novartis provide scant insights into whether QMF149 can carve out a niche in a competitive field. The trial enrolled patients whose asthma remained uncontrolled despite treatment with a medium or high-dose ICS or low-dose ICS-LABA combination. Participants received either a medium or high dose of QMF149 or a medium or high dose of an ICS.

After 26 weeks, patients on QMF149 experienced a statistically significant improvement in lung function, as measured by FEV1. The trial design, plus lack of data shared to date, make it impossible to tell whether another medium or high-dose ICS-LABA combination would have performed as well. Novartis also reported success against secondary endpoints, including one that looked at the effect of QMF149 on the ACQ-7 Asthma Control Questionnaire.   

With the efficacy data unlikely to blow existing drugs, including generics, out of the water, Novartis’ pitch for the market may rest on the dose-confirming Breezhaler device. A Novartis-sponsored study found chronic obstructive pulmonary disease patients prefer Breezhaler to GSK’s Ellipta, and the company’s release to disclose the top-line asthma findings talked up the device.

“If approved, the easy-to-use, dose-confirming, once-daily device adds an additional and important option for clinicians treating asthma. I believe that this new fixed-dose combination has the potential to improve and simplify the lives of many patients with uncontrolled asthma,” Richard van Zyl-Smit, M.D., an associate professor at the University of Cape Town Lung Institute, said in a statement.

Novartis, which shared phase 3 data on low-dose QMF149 in May, has already filed for approval of the drug in the EU, setting it up to conclude a long development program. Back in 2010, Novartis said it planned to file for approval in asthma in Europe in 2014. Novartis opted against starting U.S. development work around the same time. 

QMF149 is set to finally come to market as part of a PLATINUM development program that is also looking at QVM149, a triple-combination asthma therapy. QVM149 features a long-acting muscarinic receptor antagonist in addition to the ICS-LABA backbone found in QMF149.