……….. catching up on FDA Approvals
The FDA recently approved a new therapy, Ohtuvayre (ensifentrine) from Verona Pharma plc, for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients. Ohtuvayre is the first inhaled therapy for the maintenance treatment of COPD that combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule. Ohtuvayre is administered by oral inhalation using a standard jet nebulizer with a mouthpiece.
COPD causes difficulty in breathing and affects approximately 16 million people in the US.
According to the CDC, COPD is the sixth leading cause of death in the United States.
Ohtuvayre is the first new treatment for the inflammatory condition in over a decade. Two pharma competitors (Regeneron and Sanofi) are working on similar anti-inflammatory therapies. Ohtuvayre has a low side effect / adverse reaction profile.
CLICK HERE to access prescribing information
Verona Pharma said Ohtuvayre will launch at a wholesale price of $2,950 per month / +-$35,000 annually.
The company did not disclose plans for distribution.
Given that the potential patient population is quite large and annual cost is in the specialty pharmacy territory, we anticipate that Ohtuvayre will launch in open distribution or through a multi-SP LD network.
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