Cumberland announces ifetroban NDA filing plan after shares plummet
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Pontos principais:
- After shares declined almost 49% in Monday's trading session, Cumberland Pharmaceuticals said it will file an NDA for cardiomyopathy associated with Duchenne muscular dystrophy candidate ifetroban.
- The company held a pre-NDA meeting with the US FDA recently and intends to use the phase 2 FIGHT DMD trial as the pivotal study, along with comparison data from two natural history databases.
- The study found that a high dose of ifetroban treatment led to a significant 5.4% absolute improvement in left ventricular ejection fraction (LVEF) compared to a control group that included placebo patients as well as propensity score-matched natural history patients.
- During a Type C meeting in January, the FDA suggested a phase 3 trial and had issues regarding the FIGHT DMD results, including the suitability of the LVEF endpoint, comparator-related questions, and the development of the statistical analysis plan. Cumberland responded with additional data, natural history data from a second DMD registry, and information on how it developed its statistical analysis plan.
- The oral drug's mechanism of action is by blocking the thromboxane receptor, which plays a key role in inflammation and fibrosis.
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