Sector News

Novartis banks EC approval for Enerzair Breezhaler

July 7, 2020
Life sciences

The European Commission (EC) has approved Novartis’ Enerzair Breezhaler (indacaterol acetate, glycopyrronium bromide and mometasone furoate) for uncontrolled asthma.

More specifically, the drug has been cleared as a maintenance treatment of asthma in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist (LABA) and a high-dose of an inhaled corticosteroid (ICS) who experienced one or more asthma exacerbations in the previous year.

Once-daily Enerzair Breezhaler is the first LABA/long-acting muscarinic antagonist (LAMA)/ICS fixed-dose combination available in the EU for these patients, Novartis noted.

It also includes an optional digital companion with sensor and app that confirms inhalation of the medicine, medication reminders and access to ‘objective data’ to better support therapeutic decisions.

“Novartis is working to reimagine medicine for people with uncontrolled asthma, who find it a challenge to achieve effective symptom and exacerbation control,” said Rod Wooten, head of Global Marketing, Novartis Pharmaceuticals.

“The approval of Enerzair Breezhaler with sensor and app in the EU is an example of our commitment to utilise data and digital offerings to make asthma control an achievable goal for patients and physicians.”

“Today, over 45% of asthma patients at GINA Steps 4 and 5 remain uncontrolled, demonstrating the need for new treatments, delivery approaches and patient support to ensure that medication is taken correctly and treatment goals are reached,” added Professor David Price, chair of Primary Care Respiratory Medicine, University of Aberdeen.

“Once-daily Enerzair Breezhaler plus a digital companion could help to facilitate greater collaborative disease management between physicians and patients in the EU whose asthma remains uncontrolled, despite LABA/ICS treatment.”

The approval rides on the back for data from over 3,000 asthma patients in the Phase III IRIDIUM study, in which once-daily Enerzair Breezhaler was shown to be superior to once-daily Atectura Breezhaler in improving the lung function of patients whose asthma is uncontrolled with LABA/ICS standard-of-care treatment.

Enerzair Breezhaler utilises Vectura’s formulation IP. As such, European regulatory approval of the product has triggered a $5.0 million milestone to Vectura from Novartis, following on from $1.25 million from its Japanese approval late last month.

By: Selina McKee

Source: Pharma Times

Related News

August 4, 2020

Lilly starts phase 3 test of COVID-19 antibody in nursing homes

Life sciences

Eli Lilly has started a phase 3 trial to evaluate whether its antibody LY-CoV555 stops the residents of nursing homes from developing COVID-19. Lilly has created customized mobile research units to run […]

August 4, 2020

AbbVie, Amgen and Takeda test anti-inflammatory drugs in joint COVID-19 study

Life sciences

The drug industry has come together in unprecedented collaborative efforts to tackle COVID-19. Now, as part of an R&D alliance, three big drugmakers are running a joint clinical trial to […]

July 30, 2020

Roche bets $120M on UCB’s anti-tau Alzheimer’s antibody

Life sciences

As Roche plugs away at its anti-amyloid treatment for Alzheimer’s disease, it’s adding a tau-targeting treatment to the mix. The Swiss pharma is handing over $120 million upfront for the […]