PDR Drug Update - March 2024

An Accelerated Vaccine Approval Helps Address Viral Health Threat

The spread of chikungunya virus has been expanding across the globe. Experts presume this is partly due to changing climates as well as the growing amount and interconnectivity of populated regions. Nearly 4 million disease cases were reported in the Americas in the decade before 2024. Stemming the frequency of outbreaks has become a significant goal in order to protect populations from the health threat.

The pathogenesis of chikungunya virus disease (CHIKVD) involves transmission into humans via mosquito bites. When mosquitoes bite individuals who already carry the virus, they become infected and bring the pathogen to additional human hosts, perpetuating the cycle. Outbreaks can spread rapidly. The primary health concerns that result from infection are serious chronic arthralgia and even death. A recent article published in The Lancet showed evidence that there is an increased risk of death from complications of CHIKVD for up to three months post-infection. Notable symptoms of CHIKVD are fever, debilitating joint or muscle pain, conjunctivitis, nausea/vomiting, headache, or rash. Joint pain is sometimes persistent for months or years in certain individuals. Due to the similarities in symptoms of Dengue fever and Zika, it can be easy to misdiagnose CHIKVD. As a result, the total number of infections globally from chikungunya virus may be underestimated.

Until now, the approaches to controlling and preventing the disease have included establishing protection protocols to avoid mosquito bites, such as using protective clothing, mosquito netting, and insect repellants. Treatment involves symptom management to keep patients as comfortable as possible and to help avoid complications of the infection, especially in those at risk for severe outcomes, such as older adults, infants, or those with comorbidities. With no antiviral medication yet available, controlling the spread of chikungunya virus-carrying insects and recommending supportive care for patients, such as rest and medication to help with pain and fever, are the standard measures taken. An FDA approval for a new vaccine developed to prevent the disease heralds the first option being made available to address the unmet medical needs related to CHIKVD.

The newly approved vaccine is Ixchiq, a live-attenuated vaccine indicated for preventing disease caused by chikungunya virus in individuals aged 18 years and older who are at increased risk of exposure to the virus. Due to the consideration of chikungunya as a significant public health threat, the endorsement was granted under accelerated approval based on anti-chikungunya neutralizing antibody titers. The vaccine is administered in one dose via an intramuscular injection. A future confirmatory study will be needed to assess the risks associated with the vaccine. The Advisory Committee on Immunization Practices (ACIP) February 2024 meeting agenda included outcome reporting from an assigned Work Group reviewing chikungunya vaccine data to provide recommendations for using Ixchiq in US individuals at risk of chikungunya infection. The CDC’s ACIP website will include final recommendations when they become available.

The initial approval and continued study and review of Ixchiq are important advancements in work devoted to changing the approach to a potentially debilitating disease with limited treatment options. Stay informed about additional critical drug information 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

Amtagvi

The FDA has Amtagvi (lifileucel) suspension for intravenous infusion. Amtagvi is a tumor-derived autologous T-cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. Learn more about Amtagvi

Aurlumyn

The FDA has approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. Iloprost is a vasodilator that opens blood vessels and stops blood clotting. Learn more about Aurlumyn

Eohilia

The FDA has approved Eohilia (budesonide) oral suspension, the first oral therapy for people aged 11 years and older with eosinophilic esophagitis. Learn more about Eohilia

Exblifep

The FDA has approved Exblifep (cefepime; enmetazobactam) for injection for the treatment of patients aged 18 years and older with complicated urinary tract infections including pyelonephritis caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis, and Enterobacter cloacae complex. Learn more about Exblifep

FDA New Indications

Dupixent

The FDA has approved Dupixent (dupilumab) for the treatment of pediatric patients aged 1 to 11 years, weighing at least 15kg, with eosinophilic esophagitis (EoE). Dupixent is the first medicine approved in the US specifically indicated to treat these patients. This approval expands the initial FDA approval for EoE in May 2022 for patients aged 12 years and older, weighing at least 40kg. Learn more about Dupixent

Onivyde

The FDA has approved Onivyde (irinotecan liposome) injection plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a first-line treatment in adults living with metastatic pancreatic adenocarcinoma (mPDAC). This is the second approval for an Onivyde regimen in mPDAC, following the FDA's approval in 2015 of Onivyde plus fluorouracil and leucovorin following disease progression with gemcitabine-based therapy. Learn more about Onivyde

Tagrisso

The FDA has approved Tagrisso (osimertinib) with the addition of chemotherapy for patients with EGFR-mutated advanced lung cancer. Learn more about Tagrisso

Xolair

The FDA has approved Xolair (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with immunoglobulin E-mediated food allergy. This marks the fourth FDA-approved indication for Xolair across allergic and inflammatory conditions. Learn more about Xolair

Zynrelef

The FDA has approved an expanded indication for Zynrelef (bupivacaine/meloxicam) extended-release solution for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Zynrelef was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. Learn more about Zynrelef

FDA Recalls

Azurity Pharmaceuticals Zenzedi

Azurity Pharmaceuticals, Inc. is voluntarily recalling one lot (F230169A) of Zenzedi (dextroamphetamine sulfate) 30mg tablets, to the consumer level. The product is being recalled due to a report from a pharmacist in Nebraska who opened a bottle of Zenzedi 30mg tablets and found tablets of carbinoxamine maleate, an antihistamine drug. Learn more about the Zenzedi recall

Haleon Robitussin

Haleon is voluntarily recalling eight lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult to the consumer level. The product is being recalled due to microbial contamination. Learn more about the Robitussin recall

Insight Pharmaceuticals Ting

Insight Pharmaceuticals is voluntarily recalling two lots of Ting 1% tolnaftate athlete's foot spray antifungal spray liquid, to the consumer level. A recent review by our manufacturer and their third-party lab found that samples from two lots of the product contained elevated levels of benzene. Learn more about the Ting recall

Neptune Resources Products

Neptune Resources is voluntarily recalling all lots of Neptune's Fix Elixir, Neptune's Fix Extra Strength Elixir, and Neptune's Fix Tablets, to the consumer level. The products are being recalled because they contain tianeptine, an ingredient not FDA-approved for medical use. Learn more about the Neptune Resources products recall

Today the World Arize

Today the World is voluntarily recalling one lot of Arize herbal dietary supplement capsules, to the consumer level. FDA analysis has found the products to contain undeclared nortadalafil (structurally similar to tadalafil). Learn more about the Today the World Arize recall

Today the World Capsules

Today the World is voluntarily recalling two lots of Sustain herbal dietary supplement capsules and one lot of Schwinnng capsules, to the consumer level. FDA analysis has found the products to contain undeclared tadalafil and nortadalafil (structurally similar to tadalafil). Learn more about the Today the World capsules recall

March 2024