First Inhaled COPD Therapy In Over 2 Decades - FDA Approves Verona Pharma's First Commercial Product

On Wednesday, the FDA approved Verona Pharma plc’s VRNA 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.

Related: Verona Pharma’s Promising COPD Treatment Puts It in GSK’s Acquisition Crosshairs, Analysts Predict Big Moves.

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 requiring high inspiratory flow rates or complex hand-breath coordination.

The US approval of Ohtuvayre was based on extensive data, including the Phase 3 ENHANCE trials.

In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits 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 says it is fully staffed to launch and expects Ohtuvayre to be available in the third quarter of 2024 through an exclusive network of specialty pharmacies.

“Physicians are wildly excited about this drug because it is very safe, and it helps patients breathe to a measurable extent,” a BTIG analyst told Reuters.

Reuters report added the drug could generate $3.6 billion in peak sales.

Citing Chief Commercial Officer Christopher Martin, Reuters highlighted, “The company expects to have around 100 sales representatives to reach about 15,000 physicians and is “in a very good position to execute on that” if it gets approval.

Most recently, the FDA extended the target action date of priority review of supplemental application seeking approval for Sanofi SA SNY and Regeneron Pharmaceutical Inc’s REGN Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD), a lung disease usually caused by smoking.

The revised target action date is September 27, 2024.

Price Action: At last check on Thursday, VRNA shares were up 2.38% at $15.04.

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