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Breakthrough Achievement: FDA Approves Verona Pharma’s Inhaled COPD Therapy

FDA Approves Verona Pharma's Inhaled COPD Therapy

United States: Recently on Wednesday a U.K based company reported that the United States Food and Drug Administration has granted approval to a treatment from Verona Pharma for a chronic lung disease that majorly affects the smoker to an extent.

FDA Approval Boosts Verona Pharma Shares

U.S listed the provided shares of the company which approximately surged around 11 percent in extended trading. The U.S FDA’s assent for the therapy, to be sold under the brand named Ohtuvayre, is the very first company’s first and provides a new inhaled non-steroidal treatment for long term obstructive pulmonary disease.

Innovative Treatment for Chronic Lung Disease

COPD, a chronic condition which causes restricted airflow and breathing problems, commonly affects cigarette smokers and is also known as “smoker’s lungs”. Other contributing factors for COPD include fumes, chemicals and dust in many working environments.

COPD: A Significant Health Concern

Based on the government data provided, it affects around 16 million Americans and ranks as the sixth most common cause of death in the nation. The efficacy and safety data from two late-stage trials supporting Verona’s application showed that Ohtuvayre improved lung function and symptoms, significantly lowering the risk of exacerbation in individuals with mild-to-severe COPD.

The treatment is a kind of single-drug therapeutic intended to lessen lung inflammation without the use of steroids by relaxing the muscles surrounding the airways, thus facilitating breathing.


“Before the regulator makes its decision, physicians are wildly excited about this drug because it is very safe and helps patients breathe to a measurable extent,” BTIG analyst Thomas Shrader told Reuters.

Medical Community and Market Outlook


Shrader calculated that the drug’s peak sales may bring in $3.6 billion. Before the FDA makes its judgment, Chief Commercial Officer Christopher Martin told Reuters that the company is “in a very good position to execute on that” and anticipates having about 100 sales reps to contact approximately 15,000 physicians.

Future Plans and Market Dynamics

The particular company has said that it is planned to provide details on pricing during an investor conference call recently on Thrusday and on top of that the add-on COPD drug market is seeing interest from larger drugmakers as well, especially Regeneron and Sanofi’s blockbuster anti-inflammatory drug Dupixent, although the FDA has extended its review deadline to the Sept. 27 in late May.

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