Phathom Pharmaceuticals announced Wednesday that the FDA approved Voquezna for all grades of erosive gastroesophageal reflux disease (GERD) and for the relief of heartburn associated with the disease.
Vonoprazan is a first-in-class oral potassium-competitive acid blocker (PCAB) that represents the “first major innovation” in erosive gastroesophageal reflux disease in three decades, the company said. This condition, also known as erosive esophagitis or erosive acid reflux, is characterized by stubborn heartburn and, if left untreated, can lead to Barrett’s esophagus, a recognized precursor to esophageal cancer.
Phase III data from the PHALCON-EE study supported this approval. The double-blind trial, which randomized more than 1,000 patients in the United States and abroad with various degrees of erosive GERD, showed that PCABs were noninferior in healing and superior to proton pump inhibitors in maintaining healing ( PPI) Lansoprazole (Prevacid).
“For many GERD patients with erosive esophagitis, the response to current treatments is suboptimal, causing them to Healing is incomplete and symptoms persist.” “FDA approval of Voquezna (vonoprazan) provides healthcare providers with a new first-in-class treatment option that shows better efficacy in the most difficult-to-treat GERD patients with erosive esophagitis. Fast healing effect.”
At 8 weeks into the study, the complete cure rate for all grades was 93% with the 20 mg dose of vonoprazan and 85% with the 30 mg dose of lansoprazole (ask<0.0001 (noninferiority)), and patients taking vonoprazan had more heartburn-free days during the cure portion of the trial. Vonoprazan also showed a significant advantage in the cure rate for patients with moderate to severe disease after 2 weeks, as measured by the Los Angeles Classification System (70% vs 53%, ask=0.0008).
Additionally, the drug “provided better maintenance of healing in all grades of erosive esophagitis than lansoprazole, a commonly used proton pump inhibitor, and was effective on most days of the trial.” Provides 24-hour heartburn relief,” said Howden, one of the researchers.Vonorazan Research Helicobacter pylori infections, the drug is also approved for use in combination with antibiotics.
During maintenance, lower doses of the drug (vonoprazan 10 mg, lansoprazole 15 mg) were used. PCAB proved superior to lansoprazole across all disease levels at 6 months, with 79% of participants assigned to vonoprazan maintaining healing compared with 79% of participants assigned to lansoprazole. The proportion is 72%. The moderate to severe subset experienced greater between-group differences (75% vs. 61%, respectively). ask=0.049).
According to the drugmaker, similar rates of adverse events (AEs) across drugs were observed in PHALCON-EE. The label for vonoprazan lists common AEs during the 8-week healing phase, including gastritis (3%), diarrhea (2%), bloating (2%), abdominal pain (2%), and nausea (2%). During maintenance, the most common AEs of PCAB included gastritis (6%), abdominal pain (4%), dyspepsia (4%), hypertension (3%), and urinary tract infection (3%).
This drug is contraindicated for use with rilpivirine-containing regimens used to treat HIV.Additional warnings and precautions include that reactions to vonoprazan do not exclude gastric malignancy, the potential risk Clostridium difficileassociated diarrhea and fractures, and long-term use of this drug may increase the risk of fundic gland polyps and vitamin B12 deficiency. Patients who develop acute tubulointerstitial nephritis or severe cutaneous adverse reactions after treatment should discontinue the drug.
Phathom said Vonoprazan is available in 10 mg and 20 mg tablets and is expected to be available in December. The recommended dose is 20 mg once daily during the 8-week healing phase and 10 mg once daily during the 6-month maintenance phase.
