The U.S. Food and Drug Administration (FDA) approved Voquezna on October 19, 2021. [1]
What is Voquezna used for?
Voquezna is a prescription medicine used to treat Helicobacter pylori (H. pylori) infection in adults. [1]
How does Voquezna work?
Voquezna is a combination therapy that includes vonoprazan, amoxicillin, and clarithromycin. Vonoprazan is a potassium-competitive acid blocker that reduces stomach acid. Amoxicillin and clarithromycin are antibiotics that kill H. pylori bacteria. [1]
When was the drug submitted for approval?
The New Drug Application (NDA) for Voquezna was submitted to the FDA in April 2021. [2]
What other approvals has Voquezna received?
Voquezna received approval for a new indication for the treatment of H. pylori infection in adults in March 2023. [3]
Who manufactures Voquezna?
Voquezna is manufactured by Phathom Pharmaceuticals. [1]
What is the patent status of Voquezna?
Information on the specific patent expiry dates for Voquezna is available through patent databases. DrugPatentWatch.com provides comprehensive data on drug patents, including those for Voquezna. [4]
What are the potential side effects of Voquezna?
Common side effects of Voquezna include diarrhea, nausea, vomiting, abdominal pain, bloating, headache, and changes in taste. [1]
What are the risks associated with H. pylori infection treatment?
Treating H. pylori infection carries risks such as the development of antibiotic resistance, which can make future infections harder to treat. Allergic reactions to the medications are also a possibility. [1]
How does Voquezna compare to other H. pylori treatments?
Voquezna offers a novel approach to H. pylori eradication by incorporating vonoprazan, a P-CAB, alongside traditional antibiotics. This differs from many standard triple or quadruple therapy regimens that rely on proton pump inhibitors (PPIs). Clinical studies have shown high eradication rates for Voquezna. [1][3]
What is the clinical data supporting Voquezna's efficacy?
Clinical trials have demonstrated that Voquezna achieves high H. pylori eradication rates. For instance, in one pivotal Phase 3 study, the dual- and triple-therapy regimens containing vonoprazan showed success in eradicating the infection. [1][3]
What is the mechanism of action of vonoprazan in Voquezna?
Vonoprazan is a potassium-competitive acid blocker (P-CAB). It works by reversibly inhibiting the H+/K+-ATPase enzyme system, also known as the proton pump, in gastric parietal cells. This inhibition leads to a rapid and sustained decrease in gastric acid secretion, creating an environment that can enhance the efficacy of antibiotics against H. pylori. [1]
Sources:
[1] https://www.phathompharma.com/
[2] https://www.fiercepharma.com/
[3] https://www.outsourcedpharma.com/
[4] https://drugpatentwatch.com/