Having delivering a submission for ensifentrine to the desks of US regulators, Verona Pharma plc is now putting in place a strategy designed to give its closely watched chronic obstructive pulmonary disease (COPD) drug the best chance of a strong launch.
Key Takeaways
- Verona has got a PDUFA date in June 2024 for its COPD candidate ensifentrine
- Coverage on Medicare Part B rather than Part D should ensure a strong launch, say Jefferies analysts
- The UK firm plans to go
Earlier this month, the US Food and Drug Administration accepted for review the UK company’s filing seeking approval of ensifentrine for the maintenance treatment of patients with COPD. The new drug application included efficacy and safety data from the two Phase III ENHANCE trials, in which the inhaled first-in-class, selective dual inhibitor of phosphodiesterase-3 (PDE3) and PDE4 demonstrated improvements in lung function and substantially reduced the rate and risk of COPD exacerbations
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