Here is information on the latest US FDA approvals, the week of October 2 – October 6, 2023
Novavax COVID Vaccine
The updated COVID-19 vaccine made by Novavax is now approved for use in the US for individuals aged 12 and older. The other two COVID vaccines already approved are from Pfizer and Moderna and are both mRNA vaccines. mRNA vaccines carry instructions for making a SARS-CoV-2 protein, whereas Novavax’s vaccine contains a purified, full-length recombinant Spike (rS) protein that stimulates the immune system to generate a protective immune response, specifically by eliciting antibodies against the Spike protein of the SARS-CoV-2 virus. This latest vaccine is expected to be available to the general public within the next week.
Rivfloza (Nedosiran) for Primary Hyperoxaluria
The FDA has approved Rivfloza (nedosiran), an RNA interference therapy, as a treatment to lower urinary oxalate levels in patients with primary hyperoxaluria type 1 (PH1) with relatively preserved kidney function. The approval was granted last week to Novo Nordisk. Primary hyperoxaluria (PH) is a rare genetic disease that causes overproduction of oxalate by the liver and is estimated to affect about 2000 people in the US. PH1 is the most clinically prevalent form of PH, accounting for about 80% of cases, and the most severe of the three subtypes of PH. The disorder leads to progressive kidney damage. Rivfloza makes use of the GalXC™ RNAi platform and inhibits production of the liver-specific lactate dehydrogenase enzyme, which is the final step of oxalate production. Rivfloza is approved for use in patients aged 9 years and older. Novo Nordisk plans to make Rivfloza available for eligible patients in early 2024.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215842s000lbl.pdf
Intravenous Cosentyx for Rheumatic Disease
The FDA has approved an intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA). According to a press release from the manufacturer, Novartis, Cosentyx is the only approved IV formulation that targets and blocks interleukin-17A (IL-17A), and the only non-tumor necrosis factor alpha (TNF-α) IV option available in all these indications. The new IV administration option will be available in Q4 of 2023. Cosentyx was first approved as a subcutaneous formulation in 2015.
https://www.novartis.com/us-en/sites/novartis_us/files/cosentyx.pdf
Abrilada Adalimumab Biosimilar
Abrilada has received the “interchangeability designation” as a biosimilar to adalimumab. An interchangeable designation is granted by the FDA only to those biosimilars that meet additional data requirements demonstrating that patients who alternate between the reference product and the biosimilar will have the same clinical result as patients who are being treated with the reference product alone. This approval of Abrilada, manufactured by Pfizer, means that Abrilada can be substituted for adalimumab at the pharmacy level without the intervention or required notification of the prescribing provider (where state law allows). Abrilada was first approved in 2019 and is used for the treatment of several rheumatic disease including rheumatoid arthritis and inflammatory bowel disease. The FDA’s decision was based on data from the phase 3 REFLECTIONS B538-12 study, in which the biosimilar demonstrated “similar outcomes” regarding pharmacokinetics, safety and efficacy among patients who switched multiple times between the reference product and Abrilada. Another biosimilar, cyltezo from Boehringer Ingelheim was the first adalimumab biosimilar to receive approval as an interchangeable in July 2023.
https://labeling.pfizer.com/ShowLabeling.aspx?id=12780
Large Volume Injector for Empaveli in PNH
The FDA has approved an Injector (enFuse®) for the large-volume subcutaneous delivery of Empaveli (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria (PNH). According to a press release from the Injector’s manufacturer, Enable Injections, Inc. the Empaveli Injector “is the first purely mechanical, large-volume, on-body subcutaneous drug delivery device.” The wearable injector’s so called enFuse® technology allows hands-free, hidden needle drug delivery of up to 25 mL. The current approval for delivery of Empaveli, made by Apellis Pharmaceuticals, is the first approval, but the Cincinnati-based Enable Injections is working with several other manufacturers including CSL Behring, Roche/Genentech, Sanofi, and Viridian Therapeutics.
https://www.prnewswire.com/news-releases/enable-injections-receives-first-us-food-and-drug-administration-fda-approval-301943533.html
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