August 2024

PDR Drug Update 

Chronic Esophageal Disease Gets New Treatment Approval

Eosinophilic esophagitis, or EoE, is considered a rare disease, affecting under an estimated 155,000 individuals in the US. However, it is not classified as a rare condition in Europe, and its prevalence has doubled in America over the past twenty years. Given the present and potential impact, new and effective treatments for the chronic digestive disorder are desired. A recent FDA approval for an oral therapy for EoE is helping meet that need.

Many EoE patients are initially misdiagnosed with gastroesophageal reflux disease, or GERD, due to similarities in some of the common symptoms. EoE patients may experience difficulty swallowing, known as dysphagia, or may even have occurrences of food sticking in their throat (impaction), causing choking. Nausea, pain, low appetite for food, weight loss, and (in pediatric and adolescent patients) a failure to thrive are all symptoms of EoE.

The specific cause for EoE is unknown, and the underlying mechanisms remain incompletely understood. It is believed that the inflammation and irritation in the esophagus of patients with the condition occur as an immune response to allergens through environmental exposure or ingestion. When hypersensitivity occurs in a patient, the body reacts with a significant cellular response, resulting in the overproduction and accumulation of white blood cells called eosinophils.

An upper endoscopy is the typical approach to diagnosing a patient with EoE. During the procedure, the esophagus, stomach, and duodenum are examined. Confirmation of any inflammation, damage, strictures, or thickening of the esophageal wall is needed. An endoscopic image of EoE shows rings of irregular tissue, known as esophageal rings, which have resulted from chronic inflammation. However, an imaging procedure may not be conclusive as a patient with EoE can have an esophagus that appears normal during an endoscopy. Therefore, endoscopy with biopsy is a much more reliable diagnosis method. A pathologist will study the samples obtained through biopsies to determine the number of visible eosinophils. EoE is suspected when the findings show >15 eosinophils per high-powered microscopic field.

The first step of treating EoE involves dietary management, such as an allergen elimination diet, an elemental diet, or a food trial. Medication options for treatment have been limited to proton pump inhibitors or swallowed topical corticosteroids, with the latter commonly in an off-label scenario. Now, the FDA has approved Eohilia (budesonide oral suspension) for 12 weeks of treatment in adult and pediatric patients aged 11 years and older with EoE. The approval offers an additional and much-needed option that can help give flexibility and consistency in treatment with an oral medication for EoE. Stay informed about additional medication advances for EoE 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

Ahzantive

The FDA has approved Ahzantive (aflibercept-mrbb), as a biosimilar to Eylea (aflibercept). Ahzantive has been approved for the treatment of patients with age-related neovascular (wet) macular degeneration and other serious retinal diseases such as diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion. Learn more about Ahzantive

Chewtadzy

The FDA has approved Chewtadzy (tadalafil) chewable tablets for the treatment of erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia (BPH), ED, and the signs and symptoms of BPH (ED/BPH). Learn more about Chewtadzy

Epysqli

The FDA has approved (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). Epysqli has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis and with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy. Learn more about Epysqli

Kisunla

The FDA has approved Kisunla (donanemab-azbt) 350mg/20mL once-monthly injection for IV infusion for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment as well as people with the mild dementia stage of AD, with confirmed amyloid pathology. Learn more about Kisunla

Nypozi

The FDA has approved Nypozi (filgrastim-txid) injection for subcutaneous or intravenous use, as a biosimilar to Neupogen (filgrastim). Nypozi is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. Learn more about Nypozi

Ohtuvayre

The FDA has approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease in adult patients. Learn more about Ohtuvayre

Pyzchiva

The FDA has approved Pyzchiva (ustekinumab-ttwe), as a biosimilar to Stelara (ustekinumab). Pyzchiva is approved for all indications of the reference medicine, including treatment of adult patients with moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis, as well as pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis. Learn more about Pyzchiva

Sirturo

The FDA has granted traditional approval to Sirturo (bedaquiline) as part of combination therapy in adult and pediatric patients (aged 5 years and older and weighing at least 15kg) with pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampicin and isoniazid. With the FDA's approval, label restrictions that were included when the medicine was granted accelerated approval in the US in December 2012 have been removed. Learn more about Sirturo

Tepylute

The FDA has approved Tepylute (thiotepa) for treatment of adenocarcinoma of the breast or ovary. Learn more about Tepylute

Voquezna

The FDA has approved Voquezna (vonoprazan) 10mg tablets for the relief of heartburn associated with non-erosive gastroesophageal reflux disease in adults. Learn more about Voquezna

FDA New Indications

Velphoro

The FDA has approved an expanded pediatric population for Velphoro (sucroferric oxyhydroxide) chewable tablet for oral use. It is now approved for the control of serum phosphorus levels in adult and pediatric patients aged 9 years and older with chronic kidney disease on dialysis. Learn more about Velphoro

Zoryve

The FDA has approved Zoryve (roflumilast) cream, 0.15%, for the treatment of mild-to-moderate atopic dermatitis in adult and pediatric patients aged 6 years and older. Learn more about Zoryve

FDA New Dosing

Vabysmo

The FDA has approved Vabysmo (faricimab) 6mg single-dose prefilled syringe (PFS) for use in the treatment of age-related neovascular (wet) macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion. Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials in an alternative, ready-to-use format. Vabysmo will continue to be available in a 6mg vial. Learn more about Vabysmo

FDA Recalls

American Health Packaging Potassium Chloride

On behalf of BluePoint Laboratories, American Health Packaging is voluntarily recalling 21 batches of potassium chloride extended-release capsules, USP (750mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. Learn more about the American Health Packaging potassium chloride recall

Endo USA, Inc Clonazepam

Endo USA, Inc is voluntarily recalling one lot of clonazepam orally disintegrating tablets, USP (C-IV) 0.25mg tablets, which may also appear as clonazepam orally disintegrating tablets, USP (C-IV) 0.125 tablets 60-count pack, to the consumer level. The product lot is being recalled due to mislabeling. Learn more about the Endo USA, Inc clonazepam recall

Guru Inc. Infla-650

GURU INC. is voluntarily recalling Infla-650 herbal dietary supplement capsules, Lot No. IN-032, 700mg, to the consumer/user level. Infla-650 has been found to be tainted with acetaminophen, diclofenac, and phenylbutazone, which are not listed on the label. Learn more about the Guru Inc. Infla-650 recall

Hikma Acetaminophen

Hikma Pharmaceuticals is extending its voluntary recall of one lot (lot 24070381) of acetaminophen injection, 1000mg/100mL (10mg/mL), to the consumer/user level. The product is being recalled due to the potential presence of a bag labeled dexmedetomidine HCl injection (400mcg/100mL) inside the overwrap that is labeled acetaminophen injection, 1000mg/100mL (10mg/mL). Learn more about the Hikma acetaminophen recall

Main Products, Inc. Umary

Main Products, Inc. is voluntarily recalling all lots of “Umary acido hialuronico, suplemento alimenticio – 30 capletas de 850mg” to the consumer level. FDA laboratory analysis confirmed that Umary has been found to be tainted with diclofenac and omeprazole. Learn more about the Main Products, Inc. Umary recall

SoloVital.com Umary

SoloVital.com is voluntarily recalling all lots of “Umary acido hialuronico, suplemento alimenticio – 30 capletas de 850mg” to the consumer level. FDA laboratory analysis confirmed that Umary has been found to be tainted with diclofenac and omeprazole. Learn more about the SoloVital.com Umary recall

Supercore Products Group Hard Steel

Supercore Products Group is voluntarily recalling Hard Steel Capsules and Gold Hard Steel Plus Liquid, to the consumer level. FDA analysis has found these products to be tainted with sildenafil and acetaminophen. Learn more about the Supercore Products Group Hard Steel recall

Labeling Updates - No updates this month