FDA approves two vonoprazan therapies for H. pylori eradication

 

The U.S. Food and Drug Administration has approved two vonoprazan-based treatments for Helicobacter pylori infection: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.

Vonoprazan is an oral potassium-competitive acid blocker and “the first innovative acid suppressant from a new drug class approved in the United States in over 30 years,” the company said in a news release announcing the approval.

“The approval of Voquezna treatment regimens offers physicians and patients two therapeutic options that showed superior eradication rates compared to proton pump inhibitor-based (PPI) lansoprazole triple therapy in the overall patient population in a pivotal trial,” Terrie Curran, president and CEO of Phathom Pharmaceuticals, said in the release.

“H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment regimens, resulting in treatment failures and complications for patients,” Ms. Curran noted.

“New therapies that have the potential to address the limitations of current treatments are needed, and we look forward to bringing these innovative vonoprazan-based treatment options to the millions of H pylori sufferers in the United States,” Ms. Curran said.

FDA approval of vonoprazan triple and dual therapy was based on safety and efficacy data from the phase 3 PHALCON-HP trial involving 1,046 patients.

As earlier reported, both treatment regimens were noninferior to PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) in patients with H. pylori strains that were not resistant to clarithromycin or amoxicillin at baseline.

In this analysis, the eradication rate was 78.8% with PPI-based triple therapy, compared with 84.7% with vonoprazan triple therapy and 78.5% with vonoprazan dual therapy.

Vonoprazan triple and dual therapy were both superior to PPI-based triple therapy among all patients, including patients with clarithromycin-resistant H. pylori.

Among patients with clarithromycin-resistant H. pylori, 31.9% achieved eradication with PPI triple therapy, compared with 65.8% with vonoprazan triple therapy and 69.6% with vonoprazan dual therapy.

Among all patients, 68.5% achieved eradication with PPI triple therapy, 80.8% with vonoprazan triple therapy and 77.2% with vonoprazan dual therapy.

Adverse event rates for the vonoprazan-based regimens were comparable to lansoprazole triple therapy. Full prescribing information is available online.

“As a practicing physician, I am excited about the potential of two novel, first-line H. pylori treatment options,” William D. Chey, MD, chief of gastroenterology & hepatology at the University of Michigan, Ann Arbor, said in the news release.

“I believe the added flexibility of having two additional effective therapies, including a dual therapy option that does not contain clarithromycin, offers the potential to improve clinical outcomes in patients with H. pylori infection,” Dr. Chey added.

The company expects to launch both products in the third quarter of 2022. Both treatment regimens will be supplied in convenient blister packs to help promote compliance.

A version of this article first appeared on Medscape.com.

 

The U.S. Food and Drug Administration has approved two vonoprazan-based treatments for Helicobacter pylori infection: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.

Vonoprazan is an oral potassium-competitive acid blocker and “the first innovative acid suppressant from a new drug class approved in the United States in over 30 years,” the company said in a news release announcing the approval.

“The approval of Voquezna treatment regimens offers physicians and patients two therapeutic options that showed superior eradication rates compared to proton pump inhibitor-based (PPI) lansoprazole triple therapy in the overall patient population in a pivotal trial,” Terrie Curran, president and CEO of Phathom Pharmaceuticals, said in the release.

“H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment regimens, resulting in treatment failures and complications for patients,” Ms. Curran noted.

“New therapies that have the potential to address the limitations of current treatments are needed, and we look forward to bringing these innovative vonoprazan-based treatment options to the millions of H pylori sufferers in the United States,” Ms. Curran said.

FDA approval of vonoprazan triple and dual therapy was based on safety and efficacy data from the phase 3 PHALCON-HP trial involving 1,046 patients.

As earlier reported, both treatment regimens were noninferior to PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) in patients with H. pylori strains that were not resistant to clarithromycin or amoxicillin at baseline.

In this analysis, the eradication rate was 78.8% with PPI-based triple therapy, compared with 84.7% with vonoprazan triple therapy and 78.5% with vonoprazan dual therapy.

Vonoprazan triple and dual therapy were both superior to PPI-based triple therapy among all patients, including patients with clarithromycin-resistant H. pylori.

Among patients with clarithromycin-resistant H. pylori, 31.9% achieved eradication with PPI triple therapy, compared with 65.8% with vonoprazan triple therapy and 69.6% with vonoprazan dual therapy.

Among all patients, 68.5% achieved eradication with PPI triple therapy, 80.8% with vonoprazan triple therapy and 77.2% with vonoprazan dual therapy.

Adverse event rates for the vonoprazan-based regimens were comparable to lansoprazole triple therapy. Full prescribing information is available online.

“As a practicing physician, I am excited about the potential of two novel, first-line H. pylori treatment options,” William D. Chey, MD, chief of gastroenterology & hepatology at the University of Michigan, Ann Arbor, said in the news release.

“I believe the added flexibility of having two additional effective therapies, including a dual therapy option that does not contain clarithromycin, offers the potential to improve clinical outcomes in patients with H. pylori infection,” Dr. Chey added.

The company expects to launch both products in the third quarter of 2022. Both treatment regimens will be supplied in convenient blister packs to help promote compliance.

A version of this article first appeared on Medscape.com.

 

The U.S. Food and Drug Administration has approved two vonoprazan-based treatments for Helicobacter pylori infection: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), both from Phathom Pharmaceuticals.

Vonoprazan is an oral potassium-competitive acid blocker and “the first innovative acid suppressant from a new drug class approved in the United States in over 30 years,” the company said in a news release announcing the approval.

“The approval of Voquezna treatment regimens offers physicians and patients two therapeutic options that showed superior eradication rates compared to proton pump inhibitor-based (PPI) lansoprazole triple therapy in the overall patient population in a pivotal trial,” Terrie Curran, president and CEO of Phathom Pharmaceuticals, said in the release.

“H. pylori eradication rates continue to decline in part due to antibiotic resistance, inadequate acid suppression, and complex treatment regimens, resulting in treatment failures and complications for patients,” Ms. Curran noted.

“New therapies that have the potential to address the limitations of current treatments are needed, and we look forward to bringing these innovative vonoprazan-based treatment options to the millions of H pylori sufferers in the United States,” Ms. Curran said.

FDA approval of vonoprazan triple and dual therapy was based on safety and efficacy data from the phase 3 PHALCON-HP trial involving 1,046 patients.

As earlier reported, both treatment regimens were noninferior to PPI-based triple therapy (lansoprazole with amoxicillin and clarithromycin) in patients with H. pylori strains that were not resistant to clarithromycin or amoxicillin at baseline.

In this analysis, the eradication rate was 78.8% with PPI-based triple therapy, compared with 84.7% with vonoprazan triple therapy and 78.5% with vonoprazan dual therapy.

Vonoprazan triple and dual therapy were both superior to PPI-based triple therapy among all patients, including patients with clarithromycin-resistant H. pylori.

Among patients with clarithromycin-resistant H. pylori, 31.9% achieved eradication with PPI triple therapy, compared with 65.8% with vonoprazan triple therapy and 69.6% with vonoprazan dual therapy.

Among all patients, 68.5% achieved eradication with PPI triple therapy, 80.8% with vonoprazan triple therapy and 77.2% with vonoprazan dual therapy.

Adverse event rates for the vonoprazan-based regimens were comparable to lansoprazole triple therapy. Full prescribing information is available online.

“As a practicing physician, I am excited about the potential of two novel, first-line H. pylori treatment options,” William D. Chey, MD, chief of gastroenterology & hepatology at the University of Michigan, Ann Arbor, said in the news release.

“I believe the added flexibility of having two additional effective therapies, including a dual therapy option that does not contain clarithromycin, offers the potential to improve clinical outcomes in patients with H. pylori infection,” Dr. Chey added.

The company expects to launch both products in the third quarter of 2022. Both treatment regimens will be supplied in convenient blister packs to help promote compliance.

A version of this article first appeared on Medscape.com.