![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
The item has been added to your shopping cart.
Home » Drugmakers Begin Joint Trial of COVID-19 Treatments
Drugmakers Begin Joint Trial of COVID-19 Treatments
August 4, 2020
AbbVie, Amgen and Takeda Pharmaceuticals have launched a joint phase 2 trial aimed at repurposing drugs for use as COVID-19 treatments.
The trial will evaluate Amgen’s psoriasis blockbuster Otezla (apremilast), Takeda’s Firazyr (icatibant injection), an anti-inflammatory drug, and AbbVie’s cenicriviroc, an experimental drug for the treatment of nonalcoholic steatohepatitis, in severely ill, hospitalized COVID-19 patients who require high-flow oxygen.
The companies believe Otezla could suppress inflammation resulting from an immune response and Firazyr may improve pulmonary edema, while cenicriviroc may block receptors linked to COVID-19.
The I-SPY COVID trial is a collaboration among the three members of the 20-member COVID Research & Development Alliance, in partnership with the Quantum Leap Healthcare Collaborative and the FDA.
The trial will use Quantum Leap’s adaptive platform trial design, which is designed to minimize the number of participants and the time required to evaluate multiple treatments.
The drugs will be tested in combination with Gilead Sciences’ remdesivir, in a trial that will also include groups of patients given remdesivir or dexamethasone alone.
The I-SPY COVID trial is using “a timely and effective” strategy to evaluate promising treatments while “maintaining an appropriate level of safety and statistical rigor,” said Mark McClellan, a former FDA Commissioner and director of the Center for Health Policy at Duke University. — Jordan Williams
Upcoming Events
-
21Oct