FDA Tracker: Travere Secures Full Approval for IgAN Drug Filspari
In 2024, the FDA has made considerable strides in approving new therapeutics, such as Eli Lilly’s Kisunla for Alzheimer’s disease and Madrigal Pharmaceuticals’ Rezdiffra for metabolic dysfunction-associated steatohepatitis. However, there have also been several Complete Response Letters (CRLs) issued this year, indicating hurdles for various companies.
BioSpace remains dedicated to keeping you informed with our FDA Decision Tracker to follow these developments closely.
September 5
Product: Travere Therapeutics’ Filspari
Indication: IgA nephropathy
On September 5, the FDA provided full approval for Travere Therapeutics’ Filspari, completing its earlier accelerated approval from February 2023. This medication is now approved to treat primary IgA nephropathy and expands its use to delay kidney function deterioration in at-risk adult patients without the previous urinary protein level restriction.
Full approval was based on results from the Phase III PROTECT trial, where Filspari demonstrated over three times the reduction in urine protein levels compared to Avapro, its control. However, the confirmatory trial narrowly missed its primary efficacy endpoint regarding the glomerular filtration rate.
August 30
Product: Novavax’s updated COVID-19 vaccine
Indication: COVID-19
A significant update from Novavax arrived as the FDA authorized its COVID-19 vaccine as a booster, making it the third option available this fall, joining Moderna and Pfizer/BioNTech’s revisions.
Novavax’s vaccine is formulated to address the Omicron variant and is expected to help prevent severe illness, hospitalization, and mortality when administered through Emergency Use Authorization.
August 29
Product: Emergent BioSolutions’ ACAM2000
Indication: Mpox
Emergent BioSolutions saw expanded approval for its smallpox vaccine ACAM2000, now authorized for preventing mpox in individuals at high risk. This comes as the World Health Organization classified the ongoing outbreak as a public health emergency.
August 22
Product: Moderna’s Spikevax
Indication: COVID-19
The FDA approved an updated version of Moderna’s Spikevax for the fall vaccination effort, targeting the Omicron KP.2 variant as part of efforts to curb COVID-19 hospitalization rates.
August 15
Product: AstraZeneca’s Imfinzi
Indication: Perioperative non-small cell lung cancer
AstraZeneca secured a new indication for Imfinzi in treating non-small cell lung cancer when paired with cystic chemotherapy. This decision came despite previous concerns raised about the medication’s use before and after surgery due to overtreatment risks.
August 14
Product: Gilead’s Livdelzi
Indication: Primary biliary cholangitis
Gilead Sciences was rewarded for its acquisition of CymaBay with the FDA’s approval of Livdelzi, intended for treating patients suffering from the autoimmune liver disease, primary biliary cholangitis, particularly those unresponsive to standard treatment.
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