FDA NewsPerspective

FDA approves Talicia for H. pylori infection in adults

The FDA approved Talicia for the treatment of Helicobacter pylori infection in adults, manufacturer Redhill Biopharma announced.

H. pylori infection is the major cause of peptic ulcers and gastritis and is associated with an up to six-fold increased risk for gastric cancer and mucosal associated-lymphoid-type lymphoma, according to the CDC.

Redhill said Talicia (omeprazole magnesium, amoxicillin and rifabutin) is the first and only FDA-approved rifabutin-based H. pylori therapy and is designed to address the “high and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy,” which is estimated to have more than doubled between 2009-2013.

Treatment of H. pylori infection has become increasingly difficult due to growing bacterial resistance and the lack of advances in treatment options over the past decade,” Colin W. Howden, MD, Hyman Professor of Medicine and chief of the division of gastroenterology at the University of Tennessee Health Science Center, said in a news release. “Talicia offers a new effective treatment option to overcome bacterial resistance and provide optimal efficacy and I believe it could become a recommended first-line standard-of-care treatment for H. pylori infection.”

Researchers evaluated the drug in a phase 3 study in patients with confirmed H. pylori infection. Participants received four capsules of either Talicia or the active comparator three times daily for 14 days. The trial, known as ERADICATE Hp2, demonstrated 84% eradication of H. pylori infection with Talicia compared with 58% in the active comparator arm in the intent to treat population.

The FDA had accepted a new drug application for Talicia and granted it priority review in July. Redhill said the commercial launch date, which is expected for the first quarter of 2020, will be announced in a live webcast on Nov. 22.

“The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases,” Redhill CEO Dror Ben-Asher said in the release. “We are working to expand our sales force to approximately 140 representatives who will promote Talicia, [Aemcolo (rifamycin, Cosmo Pharmaceuticals)] and other gastrointestinal-focused products in our basket.” – by Caitlyn Stulpin

Disclosures: Ben-Asher is an employee of RedHill Biopharma. Howden reports no relevant financial disclosures.

The FDA approved Talicia for the treatment of Helicobacter pylori infection in adults, manufacturer Redhill Biopharma announced.

H. pylori infection is the major cause of peptic ulcers and gastritis and is associated with an up to six-fold increased risk for gastric cancer and mucosal associated-lymphoid-type lymphoma, according to the CDC.

Redhill said Talicia (omeprazole magnesium, amoxicillin and rifabutin) is the first and only FDA-approved rifabutin-based H. pylori therapy and is designed to address the “high and growing bacterial resistance and diminished efficacy of clarithromycin-based standard-of-care therapy,” which is estimated to have more than doubled between 2009-2013.

Treatment of H. pylori infection has become increasingly difficult due to growing bacterial resistance and the lack of advances in treatment options over the past decade,” Colin W. Howden, MD, Hyman Professor of Medicine and chief of the division of gastroenterology at the University of Tennessee Health Science Center, said in a news release. “Talicia offers a new effective treatment option to overcome bacterial resistance and provide optimal efficacy and I believe it could become a recommended first-line standard-of-care treatment for H. pylori infection.”

Researchers evaluated the drug in a phase 3 study in patients with confirmed H. pylori infection. Participants received four capsules of either Talicia or the active comparator three times daily for 14 days. The trial, known as ERADICATE Hp2, demonstrated 84% eradication of H. pylori infection with Talicia compared with 58% in the active comparator arm in the intent to treat population.

The FDA had accepted a new drug application for Talicia and granted it priority review in July. Redhill said the commercial launch date, which is expected for the first quarter of 2020, will be announced in a live webcast on Nov. 22.

“The FDA’s approval of Talicia demonstrates our unwavering dedication to patients suffering from gastrointestinal diseases,” Redhill CEO Dror Ben-Asher said in the release. “We are working to expand our sales force to approximately 140 representatives who will promote Talicia, [Aemcolo (rifamycin, Cosmo Pharmaceuticals)] and other gastrointestinal-focused products in our basket.” – by Caitlyn Stulpin

Disclosures: Ben-Asher is an employee of RedHill Biopharma. Howden reports no relevant financial disclosures.

    Perspective

    This is a welcome approval because we really need additional treatment options for H. pylori infection, and this is the first new treatment that has been approved for many years. This combination product will be useful and effective in clinical practice and its efficacy will not be affected by underlying clarithromycin resistance of H. pylori because it does not contain clarithromycin.

    Clarithromycin-based triple therapy is still probably one of the most commonly prescribed regimens in this country. However, we know that clarithromycin resistance by H. pylori is increasing and doctors are not usually able to test for clarithromycin resistance before starting treatment. As a result, many patients are treated with clarithromycin-containing regimens ineffectively and such treatment does not cure their infection.

    So, the availability of an effective regimen that does not contain clarithromycin is a welcome addition to what we currently have available because we would no longer have to concern ourselves with the possibility of clarithromycin resistance. Furthermore, the two antibiotics contained in this product are amoxicillin and rifabutin and we know that resistance by H. pylori to either of these two agents is very, very low in this country.

    In guidelines that were published in 2017, of which I was a co-author, we included rifabutin-based triple therapy as a second-line or salvage regimen, but that was before we had any information about this product. There is no reason why this agent should not be considered as a first-line treatment option and I think that is essentially what the FDA has approved it for. When doctors encounter patients who say they are allergic to penicillin, they need to know from the guidelines that, although a lot of people think they are allergic to penicillin, only a small minority truly are. So, if doctors considering this treatment are worried about penicillin allergy, they should consider referral to an allergist for skin testing because the vast majority of patients with apparent penicillin allergy are not truly penicillin allergic. Therefore, regimens that contain amoxicillin, including this therapy would be very useful.

    • Colin W. Howden, MD
    • Professor of medicine
      Chief, division of gastroenterology
      University of Tennessee Health Science Center

    Disclosures: Howden reports serving as a consultant for Phathom Pharmaceuticals and RedHill Biopharma.