Third COVID-19 Vaccine Approved
On Aug. 30, 2024, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for an updated version of the Novavax® COVID-19 Vaccine, Adjuvanted (2024-2025 Formula). This EUA is for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older. The 2024-2025 formula now includes a component that corresponds to the Omicron variant JN.1 strain and the 2023-2024 formula is no longer authorized for use. This approval follows the EUA of both mRNA COVID-19 vaccines, Spikevax® (Moderna) and Comirnaty® (Pfizer/BioNTech) on Aug. 22, 2024, however unlike those Novavax’s COVID-19 vaccine is protein-based. Novavax is given by healthcare providers as an intramuscular (IM) injection. In June 2024, the Centers for Disease Control and Prevention (CDC) recommended that everyone aged six months and older should receive an updated booster. For individuals who have never been vaccinated with any COVID-19 vaccine, a series of Novavax’s 2024-2025 formulation is recommended as two doses three weeks apart. For those who have received only one dose of any Novavax Covid-19 adjuvanted vaccine, administer a single dose at least three weeks after the previous dose to complete the series. For those previously vaccinated with any vaccine or completed the Novavax series, administer a single dose of Novavax 2024-2025 formulation at least two months after the previous dose. For individuals with certain kinds of immunocompromise, an additional dose may be administered at least two months following the last dose at the discretion of the healthcare provider. Vaccines should be available within the coming days. For the prescribing information on Novavax, see EUA fact sheets here.
First Ready-to-Use Version of Bortezomib Approved
The FDA approved Boruzu™ (bortezomib injection – Amneal Pharmaceuticals and Shilpa Medicare Limited) on Sept. 5, 2024, as a ready-to-use treatment for multiple myeloma and mantle cell lymphoma. Bortezomib is a proteasome inhibitor and has been available for intravenous (IV) administration since 2003 as Velcade® (Millenium Pharmaceuticals). In 2012, bortezomib was approved for subcutaneous (SC) administration as a powder requiring reconstitution before use. A clinical trial found that SC administration of bortezomib had similar efficacy with less peripheral neuropathy compared to IV administration. Boruzu reduces the pharmacy preparation steps for oncology clinicians and is expected to launch with a unique J-code in the second quarter of 2025. The prescribing information for bortezomib can be found here.
Filspari Gets Full FDA Approval
On Sept. 5, 2024, the FDA granted full approval to Filspari® (sparsentan – Travere Therapeutics) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of kidney progression. This approval also expands the indication to no longer limit its use for patients who have rapid disease progression defined as a urine protein to creatinine ratio (UPCR) over 1.5g/g. Filspari is the only oral, once-daily, non-immunosuppressive medication that inhibits endothelin-1 and angiotensin II receptors to decrease protein in the urine for adults who have IgAN that has a high likelihood of worsening. Accelerated approval was granted in 2023 based on intermediate results from the phase III PROTECT study that showed a 49.8% drop in proteinuria, a marker of kidney damage, in the group taking 400mg of Filspari versus a 15.1% decrease for those taking 300mg of irbesartan, an angiotensin II receptor blocker (ARB) commonly used to treat IgAN. Full approval is based on final results from the PROTECT study showing that Filspari significantly reduced the rate of kidney function decline at two years (eGFR -3.0mL/min/1.73m2/year) when compared to irbesartan (eGRF -4.2mL/min/1.73m2/year), showing a statistically significant treatment effect of 1.2mL/min/1.73m2/year. The proteinuria decline was initially observed and contributed to accelerated approval, which continued at the two-year mark, as well. A risk evaluation and evaluation strategy (REMS) limits its prescribing and dispensing to certified healthcare providers and its use to registered patients. Full prescribing information can be found here.