Novo Nordisk’s RivflozaTM gets the U.S. FDA approval for treatment of primary hyperoxaluria type 1 (PH1)
On 29th September, Novo Nordisk obtained approval from the U.S. FDA for RivflozaTM (Nedosiran) – a double-stranded small interfering RNA (siRNA) which is conjugated to GalNAc aminosugar residues. This siRNA targets lactate dehydrogenase A (LDHA) in hepatocytes to reduce the production of oxalate by the liver, thereby reducing subsequent oxalate burden in patients of PH1.
Originally developed and patented (US11286488) by Dicerna Pharmaceuticals in 2018, the technology got transferred to Novo Nordisk with the acquisition of Dicerna’s ribonucleic acid interference (RNAi) platform in 2021. This enabled Novo Nordisk to utilize Dicerna’s proprietary GalXC™ and GalXC-Plus™ RNAi technologies to selectively silence genes that cause intracellular diseases across hepatic and extrahepatic cell and tissue types.
The patent protection for this drug exists in Australia, Canada, China, Japan, Israel, Korea, Mexico, the United States as well as Europe. The EP counterpart of the US patent – EP3679141 has a Unitary effect registered. The request for Unitary effect was filed on 7th July 2023.
It would be interesting to see if Novo Nordisk files for patent term extensions in the subsequent years and how it competes against Alnylam’s Oxlumo, the first approved treatment for PH1 in the U.S.