Boehringer Enters Asthma Market With New Indication For Spiriva Respimat
Spiriva – the first long-acting muscarinic antagonist approved for asthma – wins broad indication; sales target is likely sizeable patient population with uncontrolled disease.
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FDA Approves GSK’s Anoro Ellipta, The First LABA/LAMA Combination
FDA approved GSK’s Anoro Ellipta as the first LABA/LAMA combination product in the U.S. for the maintenance treatment of COPD Dec. 18, positioning GSK to launch a second respiratory product months after launching Breo Ellipta.
Paxlovid Gets FDA Panel Backing For Full Approval; Combating Rebound Misperception Urged
Patient advocate is sole committee member to vote against Paxlovid favorable benefit-risk profile, saying doctors do not know how to use the treatment. Members suggest conducting natural history studies on COVID rebound and publishing data that shows no clear association with Paxlovid.
Paxlovid Is First COVID-19 Rx Product To Get AdComm On Move From EUA To Full Approval
Approval seems assured, but US FDA advisory committee is forum for sharing evidence for use of Paxlovid in those infected with the Omicron variant and in immunocompromised individuals, as well as discussing the Pfizer product’s possible association with COVID-19 rebound.