FDA Approval Granted for Novel COPD Treatment

COPD © peterscreiber.media - stock.adobe.com

Verona Pharma announced yesterday the FDA approval of Ohtuvayre (ensifentrine) for treating chronic obstructive pulmonary disease (COPD) in adult patients, according to a press release.

Ohtuvayre is administered using a standard jet nebulizer. It combines a bronchodilator and non-steroidal anti-inflammatory effects into one molecule, the first new mechanism in COPD treatment in over 20 years.

An investor presentation that took place today prices Ohtuvayre at $2,950 monthly.

It’s expected to be available through specialty pharmacies in the third quarter of 2024.

This approval is based on the results of a phase 3 ENHANCE trials, published in the American Journal of Respiratory and Critical Care Medicine last summer. Clinical benefits were seen with combination and standalone therapy.

It has the potential to cause serious side effects including breathing problems or suicidal thoughts, but the most common side effects reported in the ENHANCE trial were back pain (1.8%), high blood pressure (1.7%), bladder infections (1.3%) or diarrhea (1.0%).

The recommended dose is 3mg twice daily, once in the morning and once in the evening. Sessions should last for five to seven minutes.

Worldwide, there are more than 390 million people living with COPD. In the United States, there are 8.6 million COPD patients being treated for chronic COPD, and half of those are persistently symptomatic, regardless of therapy, the investor presentation said.

“In my experience, despite maintenance therapy, most patients report grappling with daily symptoms, including breathlessness and persistent coughing,” Michael Wells, MD, Associate Professor in the Division of Pulmonary, Allergy, and Critical Care Medicine at the University of Alabama Birmingham, said in the press release. 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.”

COPD is a chronic lung disease that causes airflow to the lungs to be obstructed. Emphysema and bronchitis are the most common forms. It’s most commonly caused by cigarette smoke or exposure to irritating gases or particulate matter, the Mayo Clinic reports. Lung damage caused by COPD cannot be reversed.