January 2025

PDR Drug Update 

Advancement in Treating Nonerosive Reflux Disease

Gastroesophageal reflux is a normal physiological process that occurs for many individuals while eating and digesting. The composition and possible effects of a person’s refluxate will differ depending on multiple variables. Acid, enzyme, pepsin, and gas concentrations all occur in assorted levels. The body’s saliva production and the typical movement in the esophagus effectively clears refluxate in most cases; however, when reflux becomes more frequent or is caustic, physical symptoms often emerge. These include the sensation known as heartburn, feelings of nausea, the need to regurgitate, and difficulty swallowing. Symptoms such as these can be experienced with or without noticeable damage to mucosal tissues. The overall condition is known as gastrointestinal reflux disease, or GERD, but can be further categorized into three phenotypes. The first is erosive reflux disease (ERD), which involves mucosal injuries as observed through endoscopy. Next is Barrett’s esophagus (BE), which can follow ERD as long-term exposure to stomach acid changes the cellular structure of the esophageal lining. The third phenotype is nonerosive GERD, sometimes referred to as NERD. In this circumstance, a patient’s esophagus has an abnormal exposure to acid, as verified with pH testing, but endoscopic assessment reveals no mucosal injury.

The typical clinical determination for patients with the symptoms of GERD is that they have the condition. However, the ambulatory reflux monitoring needed to identify all kinds of refluxes and pinpoint nonerosive GERD is not conducted in the majority of cases. Symptomatically, patients with nonerosive GERD are commonly similar to patients with BE or ERD. A significant characteristic that does indicate nonerosive GERD can be identified using transmission electron or light microscopy. These assessments will confirm the presence of dilated intracellular spaces within the squamous epithelium. Reports have shown that more than 70% of the GERD umbrella may be categorized as nonerosive GERD. The impact on the quality of life in all patients with GERD is similar. Discomfort, pain, and social and psychological detriments are all common. Clinical approaches to provide therapy target reducing the symptoms that cause these issues. Counseling for lifestyle modifications is a primary element of therapy. The American Gastroenterological Association (AGA) offers recommendations for patients with GERD symptoms, such as avoiding foods that may trigger reflux, such as fatty or acidic foods. It also suggests that patients avoid laying down directly after meals, sleep with slightly elevated head and shoulders, quit smoking, and maintain a healthy weight.

The most commonly prescribed medication for any form of GERD is proton pump inhibitors (PPIs), such as Nexium (omeprazole) or Aciphex (rabeprazole). However, for cases of nonerosive GERD, the efficacy of PPIs is often not as high as for ERD. A new class of antisecretory medication has the potential to become a favorable alternative to the use of PPIs for nonerosive GERD. Potassium-competitive acid blockers, or PCABs, can be more inhibitive of gastric acid secretion. For patients who are not satisfied with current treatment options, a new therapy that offers the potential of speedier and longer relief of heartburn symptoms that result from reflux can help improve quality of life.

The latest FDA approval for a PCAB is the expansion of the label for Voquezna (vonoprazan). Vonoprazan is now approved for use in adults for the relief of heartburn associated with nonerosive GERD, which added to the existing indications for treatment of erosive GERD and its symptoms of heartburn and for the treatment of Helicobacter pylori infection in combination with either amoxicillin or amoxicillin and clarithromycin. Guidelines for treatment of GERD do not yet include vonoprazan as a first-line therapy for nonerosive GERD. There is evidence the agent is a promising and welcome therapeutic tool for patients and providers looking to improve or resolve symptoms. Continued study will help confirm how vonoprazan may be utilized as an on-demand therapy in the future, taking advantage of its rapid onset and high efficacy. GERD is a disease with a spectrum, spanning nonerosive GERD through the potentially cancer-causing BE, so having a spectrum of therapeutic options available to manage all levels of the condition is warranted. Stay informed about treatments for GERD 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

Alhemo

The FDA has approved Alhemo (concizumab-mtci) injection for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A (congenital factor VIII deficiency) with FVIII inhibitors or hemophilia B (congenital factor IX deficiency) with FIX inhibitors. Learn more about Alhemo

Alyftrek

The FDA has approved Alyftrek (vanzacaftor/tezacaftor/deutivacaftor), a once-daily next-in-class triple combination cystic fibrosis transmembrane conductance regulator (CFTR) modulator for the treatment of cystic fibrosis in people aged 6 years and older who have at least one F508del mutation or another mutation in the CFTR gene that is responsive to Alyftrek. Learn more about Alyftrek

Crenessity

The FDA has approved Crenessity (crinecerfont) capsules and oral solution as an adjunctive treatment to glucocorticoid replacement to control androgens in adult and pediatric patients aged 4 years and older with classic congenital adrenal hyperplasia. Learn more about Crenessity

Ensacove

The FDA has approved Ensacove (ensartinib) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor. Learn more about Ensacove

Opdivo Qvantig

The FDA has approved Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20), in most previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. Learn more about Opdivo Qvantig

Ryoncil

The FDA has approved Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-derived mesenchymal stromal cell therapy indicated for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients aged 2 months and older. Learn more about Ryoncil

Steqeyma

The FDA has approved Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. Learn more about Steqeyma

Tryngolza

The FDA has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome, a rare, genetic form of severe hypertriglyceridemia that can lead to potentially life-threatening acute pancreatitis. Learn more about Tryngolza

Unloxcyt

The FDA has approved Unloxcyt (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation. Learn more about Unloxcyt

FDA New Indications

Braftovi

The FDA has approved Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test. Learn more about Braftovi

Nemluvio

The FDA has approved Nemluvio (nemolizumab) for the treatment of patients aged 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. Learn more about Nemluvio

Tevimbra

The FDA has granted approval for Tevimbra (tislelizumab-jsgr) in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1 (≥1). Learn more about Tevimbra

Trikafta

The FDA has approved the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of people with cystic fibrosis aged 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene or a mutation that is responsive to Trikafta based on clinical and/or in vitro data. In addition, safety information on liver injury and liver failure has been updated from warnings and precautions to a boxed warning. Learn more about Trikafta

Vtama

The FDA has approved Vtama (tapinarof) cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis in adults and pediatric patients aged 2 years and older. Learn more about Vtama

Zepbound

The FDA has approved Zepbound (tirzepatide) for adults with moderate-to-severe obstructive sleep apnea and obesity. Learn more about Zepbound

FDA Recalls

Alcon Systane

Alcon Laboratories is voluntarily recalling one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) to the consumer level. Alcon evaluated a consumer complaint of foreign material observed inside a sealed single-use vial and determined the material to be fungal. Learn more about the Systane recall

Astellas Astagraf XL and Prograf

Astellas Pharma US, Inc. is voluntarily recalling one lot of Prograf (tacrolimus) 0.5mg and one lot of Astagraf XL (tacrolimus) extended-release capsules, 0.5mg, to the consumer level. These products are being recalled because bottles may contain empty capsules. Learn more about the Astagraf XL and Prograf recall

Buy-herbal.com Nhan Sam Tuyet Lien Truy Phong Hoan

Buy-herbal.com is voluntarily recalling all lots within expiry of Nhan Sam Tuyet Lien Truy Phong Hoan capsules, to the consumer level. FDA analysis found these products contain undeclared furosemide, dexamethasone, and chlorpheniramine. Learn more about the Nhan Sam Tuyet Lien Truy Phong Hoan recall

Endo Adrenalin Chloride

Endo USA, Inc. is voluntarily recalling all lots within expiry of Adrenalin Chloride Solution (EPINEPHrine nasal solution, USP) 30mg/30mL (1mg/mL) 30mL vials, to the consumer level. This product is an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. In addition, the FDA has determined the product to be misbranded with a misleading label similar in appearance to the FDA-approved drug product Adrenalin (epinephrine injection, USP) (1mg/mL) 30mL vial, also produced by Endo USA, Inc. Learn more about the Adrenalin Chloride Solution recall

Gnmart Inc. Force Forever

Gnmart Inc. is voluntarily recalling all lots of Force Forever for joint pain, 60 tablets packaged in a white plastic bottle with a red cap, to the consumer level. FDA analysis has found the product to contain undeclared diclofenac and dexamethasone. Learn more about the Force Forever recall

Shoppers-Plaza Fouzee Sugarlin Herbal Formula

Shoppers-Plaza is voluntarily recalling all lots of Fouzee Sugarlin Herbal Formula capsules to the consumer level. Fouzee Sugarlin Herbal Formula is an unapproved new drug for which safety and efficacy have not been established and, therefore, subject to recall. Learn more about the Fouzee Sugarlin Herbal Formula recall

FDA Alerts

Ocaliva

The FDA has identified cases of serious liver injury among patients being treated for primary biliary cholangitis with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver. Learn more about the Ocaliva drug safety communication

Veozah

The FDA has added a Boxed Warning, its most prominent warning, to highlight the known risk of rare but serious liver injury associated with use of menopause medicine Veozah (fezolinetant). Learn more about the Veozah FDA update

Labeling Updates - No updates this month