PDR Drug Update - November 2024

Needle-free Treatment for Anaphylaxis

Epinephrine is the first-line treatment for anaphylaxis due to its ability to act quickly to reverse potentially life-threatening symptoms and stabilize the patient. It is critical for those in need of the drug to have immediate access to it, as a delay can lead to serious complications or death. A new approval for the first epinephrine nasal spray to treat anaphylaxis is an outstanding milestone in advancing care for patients at risk of severe allergic reactions.

An anaphylactic reaction can affect multiple organ systems, leading to symptoms such as difficulty breathing, throat swelling, a drop in blood pressure, and even shock. Epinephrine, also referred to as adrenaline, is a neurotransmitter and hormone with functions that are beneficial in allergic emergencies. It works by raising heart rate and blood pressure and opening the airways to improve breathing. It is a sympathomimetic drug. It causes an adrenergic receptive mechanism on effector cells and mimics most sympathetic nervous system actions, except those involving facial arteries and sweat glands.

Unfortunately, there are challenges associated with using epinephrine, such as the need for proper training in its administration, potential side effects, and limited availability in certain settings. Consequently, there have been continued research efforts to determine alternative treatments that can address these limitations and provide more effective and convenient options for patients at risk of anaphylaxis. One alternative that recently received FDA approval is Neffy (epinephrine) nasal spray. Neffy delivers the same benefits of intramuscularly administered epinephrine but in a potentially less intimidating and more accessible form. Unlike previously approved forms of epinephrine, which require injection into the thigh, Neffy is administered as a nasal spray. This delivery system may make it more convenient and less intimidating for patients and caregivers to use in an emergency situation. This can be especially important for individuals who may be hesitant to use a needle or who have difficulty with self-administration.

The approval of Neffy represents a significant advancement in the treatment of anaphylaxis and offers a promising new option for patients. However, it is important to note that while Neffy may have some advantages over injectable epinephrine, it is not a replacement for this essential medication. As with any new drug, further research and monitoring will be needed to assess the efficacy of Neffy in real-world settings. It will also be important to ensure that healthcare providers and patients have access to accurate information about Neffy, including proper administration techniques. Overall, the approval of Neffy represents a positive step forward in the management of anaphylaxis, offering a new option for patients and caregivers seeking effective and convenient treatment for this potentially life-threatening condition. Stay informed about additional medication advances for generalized allergic or hypersensitivity reactions 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

Aqneursa

The FDA has approved Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C in adults and pediatric patients weighing ≥15kg. Learn more about Aqneursa

Cobenfy

The FDA has approved Cobenfy (trospium Cl/xanomeline), an oral medication for the treatment of schizophrenia in adults. Cobenfy introduces a fundamentally new approach to treating schizophrenia by selectively targeting M 1 and M 4 receptors in the brain without blocking D 2 receptors. Learn more about Cobenfy

Flyrcado

The FDA has approved Flyrcado (flurpiridaz F 18) injection, a first-of-its-kind positron emission tomography myocardial perfusion imaging agent, for the detection of coronary artery disease. Learn more about Flyrcado

Hympavzi

The FDA has approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients aged 12 years and older with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors, or hemophilia B (congenital factor IX deficiency) without factor IX inhibitors. Learn more about Hympavzi

Itovebi

The FDA has approved Itovebi (inavolisib) in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. Learn more about Itovebi

Orlynvah

The FDA has approved Orlynvah (probenecid/sulopenem etzadroxil) for the treatment of uncomplicated urinary tract infections caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. Learn more about Orlynvah

Otulfi

The FDA has approved Otulfi (ustekinumab-aauz), a biosimilar referencing Stelara (ustekinumab). Otulfi is approved for the treatment of Crohn's disease, ulcerative colitis, moderate-to-severe plaque psoriasis, and active psoriatic arthritis. Learn more about Otulfi

PB ER Tablets

The FDA has approved pyridostigmine bromide extended-release (PB ER) tablets, for oral use. The drug is indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults developed for the US Armed Services and US allies. Learn more about PB ER Tablets

Vyloy

The FDA has approved Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin 18.2 positive as determined by an FDA-approved test. Learn more about Vyloy

FDA New Indications

Abrysvo

The FDA has approved Abrysvo (respiratory syncytial virus (RSV) vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged 18 through 59 years who are at increased risk for LRTD caused by RSV. The indication for Abrysvo previously only included those aged 60 years and older. Learn more about Abrysvo

Botox Cosmetic

The FDA has approved Botox Cosmetic (onabotulinumtoxinA) for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults. Learn more about Botox Cosmetic

Dupixent

The FDA has approved Dupixent (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent is the first biologic medicine approved in the US to treat these patients. Learn more about Dupixent

Opdivo

The FDA has approved Opdivo (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo as adjuvant treatment after surgery. Learn more about Opdivo

Sarclisa

The FDA has approved Sarclisa (isatuximab) in combination with bortezomib, lenalidomide, and dexamethasone as a first-line treatment option for adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant. Learn more about Sarclisa

Tagrisso

The FDA has approved Tagrisso (osimertinib) for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy. Learn more about Tagrisso

Vyalev

The FDA has approved Vyalev (foscarbidopa/foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson's disease. Learn more about Vyalev

FDA New Dosing

Bimzelx

The FDA has approved 320mg single-injection device presentations of Bimzelx (bimekizumab-bkzx). These new device presentations add to the currently available 1mL administration options, each containing 160mg of bimekizumab-bkzx, and mean that patients requiring a 320mg dose of bimekizumab-bkzx will have options for single-injection administration. Learn more about Bimzelx

FDA Recalls

AK Forte Dietary Supplement

C&A Naturistics is voluntarily recalling all lots of AK Forte, 400mg tablets, to the consumer level. FDA analysis has found the product to be tainted with diclofenac, dexamethasone, and methocarbamol. Products containing these ingredients cannot be marketed as dietary supplements. Learn more about the AK Forte Dietary Supplement recall

Staska Pharmaceuticals Ascorbic Acid

Staska Pharmaceuticals, Inc. is voluntarily recalling 1 lot of ascorbic acid solution for injection (preservative-free, non-corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch. Learn more about the Staska Pharmaceuticals Ascorbic Acid recall

FDA Alerts

Amniotic Fluid Eyedrops

The FDA provided an update to its April 2023 Safety Communication regarding amniotic fluid eyedrops. The update explains that the FDA received information from two consumers who reported adverse events such as shooting pain in the eyes after using Regener-Eyes, an ophthalmic drug product marketed by Regenerative Processing Plant, LLC, for dry eye conditions. Although this product is not labeled to contain amniotic fluid, the FDA has reason to believe it does. Learn more about the Amniotic Fluid Eyedrops alert

Oxbryta

The FDA is alerting patients, caregivers, and healthcare professionals that Oxbryta (voxelotor) is being voluntarily withdrawn from the market by the manufacturer due to safety concerns. Healthcare professionals should stop prescribing Oxbryta. Patients and caregivers should contact their healthcare professional about stopping Oxbryta and starting another treatment option. Learn more about the Oxbryta alert

November 2024