PDR Drug Update - October 2024

Advancing the Fight Against Influenza

Preventing and controlling seasonal influenza and its complications involves all eligible individuals being vaccinated annually. Strong provider recommendations to get vaccinated effectively increase patient acceptance and vaccination uptake. The approval for the first flu vaccine that can be self- or caregiver-administered may give a new level of accessibility to patients that can help boost adherence to recommended vaccination.

Flu vaccines for the 2024-25 season will be trivalent vaccines. All are designed to protect against three different flu viruses, including an A/H1N1 strain, an A/H3N2 strain, and a B strain from the B/Victoria lineage, which the United States Public Health Service recommended for inclusion in the annual trivalent influenza vaccine formulation. Upon FDA advisory committee discussion, the formerly included B/Yamagata lineage virus has been removed from US influenza vaccines, moving from quadrivalent to trivalent seasonal influenza vaccines. This decision was based on the fact that there were no confirmed detections of circulating B/Yamagata lineage viruses after March 2020.

Despite the CDC’s recommendation for all individuals aged 6 months and older to receive an annual flu vaccination, only approximately 50% of adults and children did so last season. With over 35 million infections and potentially 100,000 related deaths from influenza in the 2023-24 season, accessible solutions, increased education, preparation, and prevention are still crucial. In addition to vaccination, patients should be encouraged to remain vigilant with preventive actions such as hand hygiene, covering coughs and sneezes, and limiting engagement with ill people.

A new pathway to improving acceptance rates for influenza vaccination may be possible with the September 2024 approval of FluMist (influenza vaccine live, intranasal) for self- or caregiver-administration. FluMist, initially approved in 2003, is now approved for the prevention of influenza disease caused by influenza virus subtypes A and B in individuals aged 2 through 49 years and does not need to be administered by a healthcare provider. Adding this new option for those eligible to receive the vaccine has the potential to relieve some barriers to vaccination that may exist, such as an inability to visit a clinic or pharmacy. Due to timing, the at-home option will not be available for the start of this flu season but is expected for 2025.

Easier access to and supportive messaging and encouragement around influenza vaccination are effective strategies to reduce the cumulative burden of seasonal flu. Stay informed about additional medication advances for seasonal influenza by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Ebglyss

The FDA has approved Ebglyss (lebrikizumab-lbkz), a targeted IL-13 inhibitor, for the treatment of adults and children aged 12 years and older who weigh at least 88 pounds with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therapies. Learn more about Ebglyss

Miplyffa

The FDA has approved Miplyffa (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC). Miplyffa is the first NPC drug approved by the FDA. It is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients aged 2 years and older. Learn more about Miplyffa

Ocrevus Zunovo

The FDA has approved Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis in adults. Learn more about Ocrevus Zunovo

Pavblu

The FDA has approved Pavblu (aflibercept-ayyh), the fifth biosimilar referencing Eylea (aflibercept). Pavblu is approved for the treatment of retinal conditions, including neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy. Learn more about Pavblu

Tecentriq Hybreza

The FDA has approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for subcutaneous injection for patients in the US. Tecentriq Hybreza can be injected subcutaneously over approximately seven minutes, compared with 30-60 minutes for standard IV infusion of Tecentriq (atezolizumab). It will be available for all IV indications of Tecentriq approved for adults in the US, including certain types of lung, liver, skin, and soft tissue cancer. Learn more about Tecentriq Hybreza

FDA New Indications

ACAM2000

The FDA has approved a new indication for ACAM2000, to include the prevention of mpox disease in individuals determined to be at high risk for mpox infection. ACAM2000 has been approved since 2007 for the prevention of smallpox disease in individuals determined to be at high risk for smallpox infection. Learn more about ACAM2000

Bimzelx

The FDA has approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis. Learn more about Bimzelx

Dupixent

The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment for adolescent patients aged 12 to 17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). This approval expands the initial June 2019 FDA approval in CRSwNP for patients aged 18 years and older. Learn more about Dupixent

Filspari

The FDA has granted full approval to Filspari (sparsentan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. Filspari was granted accelerated approval in February 2023 based on the surrogate marker of proteinuria. Learn more about Filspari

Keytruda

The FDA has approved Keytruda (pembrolizumab), in combination with pemetrexed and platinum chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic malignant pleural mesothelioma. Learn more about Keytruda

Kisqali

The FDA has approved Kisqali (ribociclib) in combination with an aromatase inhibitor for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative stage II and III early breast cancer at high risk of recurrence, including those with node-negative disease. Learn more about Kisqali

Rybrevant

The FDA has approved Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. Learn more about Rybrevant

FDA Recalls

123herbals Vail-Bon Jie Yang Wan

123herbals is voluntarily recalling all lots of Vail-Bon Jie Yang Wan capsules to the consumer level. The product has been found to be tainted with the drug ingredients dexamethasone and chlorpheniramine. Vail Bon Jie Yang Wan capsules is an unapproved new drug for which the safety and efficacy have not been established and, therefore, subject to recall. Learn more about the 123herbals Vail-Bon Jie Yang Wan recall

Bionpharma Atovaquone

Bionpharma Inc. is voluntarily recalling a single batch (2310083) of Atovaquone oral suspension, 750mg/mL, to the consumer level. The product was manufactured by CoreRx, Inc. and distributed by Bionpharma Inc. The product was found to be contaminated with Cohnella bacteria. Learn more about the Bionpharma Atovaquone recall

Gilead Veklury

Gilead Sciences, Inc. announced it is issuing a voluntary recall of one lot of Veklury (remdesivir) for injection 100mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in the vial during the company's investigation. Learn more about the Gilead Veklury recall

FDA Alerts

Liver Injury with Veozah

The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal. Learn more about the Veozah drug safety communication

SnoreStop Nasal Spray

The FDA is warning consumers and healthcare professionals not to use SnoreStop Nasal Spray, distributed by Green Pharmaceuticals Inc., because it may have microbial contamination. SnoreStop Nasal Spray was previously sold on the company's website and other sites. Learn more about the SnoreStop Nasal Spray alert

Umary and Amazy Products

The FDA is warning consumers not to purchase or use Umary and Amazy products, marketed as dietary supplements, as they may be harmful to your health. This is due to potentially dangerous hidden drug ingredients not listed on the product label. Learn more about the Umary and Amazy products alert

October 2024