Novavax COVID Vaccine, Rivfloza (Nedosiran) for Primary Hyperoxaluria, Intravenous Cosentyx, Abrilada Adalimumab Biosimilar, Large Volume On-Body Injector

New FDA Approvals

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Novavax COVID Vaccine:The updated Novavax COVID-19 vaccine is approved for use in the US for those 12 and older and is a conventional vaccine containing purified, full-length recombinant Spike (rS) protein. This rS protein stimulates the immune system to generate a protective immune response, specifically by eliciting antibodies against the Spike protein of the SARS-CoV-2 virus.

Rivfloza (Nedosiran) for Primary Hyperoxaluria:The FDA approved Rivfloza, an RNA interference therapy, to treat primary hyperoxaluria type 1 (PH1) patients by lowering urinary oxalate levels. The medication will be available for eligible patients in 2024.

Intravenous Cosentyx:The FDA approved an intravenous (IV) version of Cosentyx for treating adults with certain rheumatic diseases, making it the only approved IV treatment that targets interleukin-17A (IL-17A). It will be available in Q4 of 2023.

Abrilada Adalimumab Biosimilar:Abrilada has been designated as interchangeable with adalimumab, meaning it can be substituted at the pharmacy level without notifying the prescribing provider. It was proven to provide similar outcomes to the reference product even when patients switched between them multiple times.

Injector for Empaveli in PNH:The FDA approved the enFuse® Injector for delivering Empaveli to adults with paroxysmal nocturnal hemoglobinuria (PNH). This device is the first purely mechanical, large-volume subcutaneous drug delivery device, and Enable Injections is collaborating with other manufacturers for its application.

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