AstraZeneca COPD Win; FDA Names Permanent Leaders — SkimNews
Get the Health newsletter
Daily health & science — research, biotech, public health, the studies worth knowing. Free.
- AstraZeneca's injectable drug reduced dangerous COPD flare-ups in a pair of late-stage trials, positioning it as a potential new option for patients with the debilitating lung condition.
- The COPD results amount to a reassuring victory for AstraZeneca, which has seen notable trial misses in recent months, most dramatically a heart disease drug failure.
- Analysts and the company project the injectable drug could reap billions in annual sales if approved, with potential applications beyond COPD including asthma.
- The FDA permanently filled four key leadership roles on Tuesday, converting three acting officials into permanent positions, following last month's nomination of Heidi Overton to lead the agency.
- Michael Davis, a psychiatrist, becomes permanent director of the Center for Drug Evaluation and Research; Karim Mikhail, a former Merck official, will lead the Center for Biologics Evaluation and Research; and Bret Koplow, an FDA attorney since 2011, will direct the Center for Tobacco Products.
Why it matters: AstraZeneca's COPD drug win restores momentum after a string of high-profile trial misses, with analysts projecting blockbuster potential across lung and asthma indications. The FDA's permanent appointments at CDER, CBER, and CTP lock in leadership across the agency's most consequential product-review centers while Overton's nomination awaits confirmation.
Ask SkimNews
