FDA Approves Ohtuvayre (ensifentrine) for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years.

Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 (“PDE3 and PDE4”) that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.

“The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” said David Zaccardelli, Pharm. D., President and Chief Executive Officer of Verona Pharma. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms.”

Michael Wells, MD, Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama Birmingham, commented: “In my experience, despite maintenance therapy, most patients report grappling with daily symptoms, including breathlessness and persistent coughing. COPD has a significant impact on both mortality and morbidity in the US, and until today, innovation in inhaled treatment modalities has been limited to combinations of existing treatment classes for over two decades. Ohtuvayre, as a first-in-class PDE3 and PDE4 inhibitor, offers a needed, unique approach and is an important advance in the treatment of COPD.”

The US approval of Ohtuvayre was based on extensive data including the Phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre was well-tolerated in a broad population of subjects with moderate to severe COPD.

The Company is fully staffed to launch and expects Ohtuvayre to be available in the third quarter 2024 through an exclusive network of accredited specialty pharmacies.

About Ohtuvayre (ensifentrine)

Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Verona has evaluated nebulized Ohtuvayre in its Phase 3 clinical program ENHANCE (“Ensifentrine as a Novel inHAled Nebulized COPD thErapy”) for COPD maintenance treatment. Ohtuvayre met the primary endpoint in both ENHANCE-1 and ENHANCE-2, demonstrating statistically significant and clinically meaningful improvements in lung function. A fixed-dose combination of ensifentrine and glycopyrrolate, a LAMA, is currently under development for the maintenance treatment of COPD. Ensifentrine has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases.

REF: https://en.wikipedia.org/wiki/Ensifentrine

FDA Approves Ohtuvayre (ensifentrine) for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)

Bevespi Aerosphere Approved by the FDA for Patients with COPD

In continuation of my update on formoterol

AstraZeneca today announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

glycopyrrolate formoterol 

Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “With the approval of Bevespi Aerosphere we are pleased to provide patients with the first LAMA/LABA in a pressurised metered-dose inhaler, delivered using our unique formulation technology. LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, which enables patients to breathe better and may help them be more active.”

Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). The FDA approval is based on the PINNACLE trial programme, which demonstrated that Bevespi Aerosphere achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its mono-components and placebo.

Bevespi Aerosphere is the first product approved using AstraZeneca’s Co-Suspension Technology. This technology enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010).

About COPD

COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD. It is estimated that eight out of 10 patients suffer symptoms at night, such as an irritative cough and difficulty breathing, frequent nocturnal awakenings, which leads to insomnia, worry and anxiety.

Bevespi Aerosphere Approved by the FDA for Patients with COPD

In continuation of my update on Formoterol

 Formoterol     glycopyrrolate

AstraZeneca announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “With the approval of Bevespi Aerosphere we are pleased to provide patients with the first LAMA/LABA in a pressurised metered-dose inhaler, delivered using our unique formulation technology. LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, which enables patients to breathe better and may help them be more active.”

Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). The FDA approval is based on the PINNACLE trial programme, which demonstrated that Bevespi Aerosphere achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its mono-components and placebo.

Bevespi Aerosphere is the first product approved using AstraZeneca’s Co-Suspension Technology. This technology enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010).

Bevespi Aerosphere Approved by the FDA for Patients with COPD

Scientists develop new drug to treat obstructive airway diseases

Scientists have developed a new drug (RPL554, see structure) that could treat obstructive airway diseases such as asthma and chronic obstructive pulmonary disease (COPD) in two ways at once, according to new research published in The Lancet Respiratory Medicine. RPL554 has the potential to both reverse the narrowing of the airways (bronchodilation) and reduce inflammation quicker and with fewer side effects than current therapies.

“Further longer term studies of RPL554 are now eagerly awaited because this could be one of the most substantial advances for some time in the management of patients with chronic airway obstruction”, writes Professor Jadwiga A Wedzicha from University College London, UK, in a linked Comment.

The unique inhaled dual inhibitor—two actions in a single molecule—works by impeding the ability of two enzymes from the phosphodiesterase family (PDE3 and PDE4) to inhibit processes that help relax airway smooth muscle and reduce inflammation.

For the past 40 years, the mainstay of treatment for asthma and COPD (eg, chronic bronchitis and emphysema) has been inhaled anti-inflammatory drugs (corticosteroids) plus bronchodilators (usually long-acting ß2 agonists). But corticosteroids can have substantial side effects, while long-acting ß2 agonists have come under scrutiny for their risk of worsening asthma symptoms. What is more, most people with severe disease and frequent flare-ups fail to achieve good control of symptoms and new treatments are needed. 

Between February, 2009 and January 3013, four small proof-of-concept clinical trials were done in the Netherlands, Italy, and the UK to assess the safety and efficacy of inhaled RPL554 in healthy participants (39 people) and people with mild-to-moderate asthma (28) and COPD (12).

In COPD patients, a single dose of nebulised RPL554 improved respiratory function, producing a 17% increase in FEV1 (forced expiratory volume at 1 second; which measures the volume of air that can be forcibly exhaled in one second after taking a deep breath)—a bronchodilator response at least as effective as the widely use ß2 agonist Salbutamol.

Ref : http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(13)70187-5/fulltext

Scientists develop new drug to treat obstructive airway diseases

FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)

  The U.S. Food and Drug Administration today approved Breo Ellipta (fluticasone furoate above structure) and vilanterol (below structure)  inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations......

FDA Approves Breo Ellipta to Treat Chronic Obstructive Pulmonary Disease (COPD)