FDA adcomm offers thumbs up on AstraZeneca's 2-in-1 asthma inhaler — but only for adults
AstraZeneca’s experimental asthma drug cruised through an FDA advisory committee, as the panel of external experts offered an overwhelming thumbs up for its use in adults.
But when it came to adolescents and kids, the adcomm was less sure.
The mixed votes could cast a shadow on the aspirations at AstraZeneca, which had proposed a broad label in its NDA filing for PT027 that covers patients 4 years or older. In convening the adcomm, the FDA had noted that the data on pediatric patients was a big focus.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.