FDA Approves Elfabrio (pegunigalsidase alfa-iwxj) for the Treatment of Adult Patients with FabryDisease
May 10, 2023MIEBO ™
May 18, 2023May 12, 2023 - The FDA approved Astellas’ Veozah (fezolinetant), an oral, nonhormonal agent for the treatment of moderate to severe vasomotor symptoms (VMS), or hot flashes, caused by menopause. Veozah works by binding to the neurokinin 3 receptor and blocking it from binding neurokinin B, thereby regulating thermoregulatory neuronal activity in the hypothalamus.
Menopausal hormone therapy (MHT) remains the gold standard for VMS, but many women are not candidates for MHT, such as those with a history or at elevated risk of estrogen-dependent cancers, those with coronary artery disease, or those with a history of stroke or venous thromboembolism. Moreover, many women refuse MHT due to safety concerns. Veozah offers a nonhormonal option for this patient population.
Before prescribing Veozah, patients should have blood work done to test liver function and injury because the drug may elevate hepatic transaminases. Routine bloodwork should be performed every 3 months for the first 9 months of using the medication.
Veozah will compete with branded and generic MHTs, as well as generic nonhormonal options, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), gabapentinoids, oxybutynin, and clonidine. With the exception of paroxetine mesylate 7.5 mg (an SSRI), which is indicated for VMS as per its FDA-approved label, these nonhormonal agents are utilized off- label in the treatment of VMS with reported effectiveness; however, many have adverse effects.
The wholesale acquisition cost (WAC) for Veozah is $550 for a 30-day supply ($6,692 per year), which is higher than that of branded and generic MHTs and nonhormonal options, and significantly higher than the Institute for Clinical and Economic Review’s (ICER’s) previously recommended range of $2,000 to $2,500 per year for women who cannot or who do not wish to take MHTs.
The most common side effects of Veozah include abdominal pain, diarrhea, insomnia, back pain, hot flush and elevated hepatic transaminases. Veozah cannot be used with CYP1A2 inhibitors. Patients with known cirrhosis, severe renal damage or end-stage renal disease should not take Veozah .
Given the large target population and high cost of Veozah relative to other therapies for VMS, IPD Analytics recommends utilization management strategies, such as step therapy and/or prior authorization, and quantity limits to manage costs.