Bepirovirsen for chronic hepatitis B now up for approval in Canada
Regulators to speed review of add-on therapy for long-term liver infection
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GlaxoSmithKline (GSK) has submitted an application to Health Canada seeking approval of its chronic hepatitis B therapy bepirovirsen for treating adults with the long-term liver infection.
The regulatory agency granted the application priority review — “underscoring the unmet need for patients” with hepatitis B, according to GSK — which shortens the review period from about 9 months to 6 months.
The filing in Canada comes on the heels of similar submissions in the U.S., the European Union, Japan, and China.
Chronic hepatitis B “imposes a significant burden on patients, increasing the risk of liver cancer and other serious liver disease,” Michelle Horn, country medical director at GSK Canada, said in a GSK press release. “The priority review of bepirovirsen is an important milestone in our efforts to transform care for people living with chronic hepatitis B.”
GSK recently announced a partnership with the China-based company Chia Tai Tianqing Pharmaceutical Group (CTTQ) to support a commercial launch in that country if the therapy is approved.
“By combining GSK’s innovation with CTTQ’s extensive local scale and execution, we want to reach more patients, deliver greater impact, and directly address one of China’s most pressing healthcare priorities,” Mike Crichton, president international at GSK, said in a company press release announcing the collaboration.
Crichton noted that “chronic hepatitis B affects 75 million people in China and is a leading cause of liver cancer in the country.”
Bepirovirsen works to destroy HBV’s genetic material
The hepatitis B virus, known as HBV, is spread by contact with bodily fluids and infects the liver, causing liver inflammation or hepatitis. In some patients, especially those infected in childhood, hepatitis B becomes a chronic or long-lasting infection that can set the stage for life-threatening liver complications.
“In Canada,” Horn noted, “these risks are exacerbated by inequities in screening, access to [tests measuring levels of HBV proteins], and connection to care.”
Bepirovirsen is designed to destroy HBV’s genetic material, thus preventing the virus from multiplying and allowing the immune system to keep it in check.
The therapy’s regulatory applications are supported mainly by data from two large Phase 3 clinical trials, B-Well 1 (NCT05630807) and B-Well 2 (NCT05630820). Together, the trials involved more than 1,800 adults with chronic hepatitis B.
These studies showed that adding bepirovirsen to standard-of-care therapies resulted in higher functional cure rates for chronic hepatitis B than standard care alone. A functional cure means that HBV’s DNA and proteins — particularly the hepatitis B surface antigen, or HBsAg — are not detectable in the blood for at least six months after stopping all treatment. This indicates that the infection is being fully contained by the body’s natural immune defenses.
GSK plans to present detailed results from both trials at a scientific conference later this month and to submit them for publication in a peer-reviewed journal.
First test approved in Canada to measure active HBV infection
In other news, Health Canada has approved the country’s first-ever point-of-care test to measure HBsAg, a marker of active HBV infection. The test from Biolytical Laboratories, called iStatis Hepatitis Surface Antigen Test or iStatis HBsAg Test, is designed to provide results in 15 minutes, allowing patients to get results at the same appointment as the blood draw.
“Too many people with hepatitis B remain undiagnosed because testing isn’t always accessible,” Robert Mackie, CEO of Biolytical, said in a company press release announcing the approval. “This authorization allows screening to move closer to the patient, whether that’s in a clinic, a mobile unit, or a community outreach setting.”
iStatis HBsAg Test is also the first hepatitis B rapid test to be authorized in all of North America, per the release.
