Roche’s chief medical officer said the longer-term results build confidence in Vabysmo.
Australian health authorities have approved new drug Vabysmo for PBS listing after its maker released two-year data confirming the therapy can improve vision with fewer treatments for people with neovascular neovascular macular degeneration age (nAMD).
The Pharmaceutical Benefits Advisory Committee (PBAC) advised the Authority required the inclusion of Roche’s Vabysmo (faricimab) for the treatment of nAMD and diabetic macular edema (DME) at its May 2022 meeting.
This month, new two-year data from two studies, known as TENAYA and LUCERNE, reinforced the long-term efficacy, safety and durability of Vabysmo in the treatment of nAMD, according to the manufacturer Roche.
Neovascular AMD affects nearly 20 million people worldwide and may require treatment with eye injections every one to two months. The two-year data were presented at the 2022 American Society of Retina Specialists Annual Scientific Meeting on July 14.
“With the potential to require fewer injections over time, Vabysmo continues to represent an important step forward for people with vision-threatening retinal diseases, and these data illustrate our commitment to redefining the standards of care and reducing the burden treatment,” Dr. Levi Garraway, chief medical officer and head of global product development at Roche, said.
The PBAC’s listing recommendation was based, among other things, on its assessment that the cost-effectiveness of faricimab would be acceptable if minimized compared to anti-VEGF treatments listed in the PBS, such as aflibercept and ranibizumab for the same indication.
“The PBAC has determined that, based on the clinical evidence provided, the claim of non-inferior comparative efficacy and safety of faricimab versus aflibercept is acceptable,” the statement of findings explains.
“The PBAC considered that there should be no additional cost to the government given the PBAC’s acceptance of the frequency of administration of faricimab, based on an analysis of the frequency of administration of faricimab during the first year of treatment, which was derived from the average doses during the first 48 weeks of treatment in the TENAYA and LUCERNE trials.
The PBAC provided similar reasoning for its recommendation to list Vabysmo on the PBS for DMO.
In the latest two-year data from both trials, Roche reported that more than 60% of people receiving Vabysmo could be treated every four months – up from 45% in the first year – while still achieving gains of vision comparable to those of the administered aflibercept. Every two months.
Almost 80% of people receiving Vabysmo could be treated every three months or more.
The company said that patients treated with Vabysmo received a median number of 10 injections over the two years compared to 15 injections for patients treated with aflibercept, which could reduce the number of injections.
Comparable reductions in central subfield (CST) thickness were observed with Vabysmo administered at intervals of up to four months compared to aflibercept administered every other month.
No new safety signals were identified and Vabysmo continued to be well tolerated, with a favorable benefit-risk profile.
One-year primary analyzes formed the basis of recent nAMD approvals in the United States, Japan, United Kingdom and several other countries around the world. Vabysmo is also approved in these countries for DMO.
Vabysmo is currently under review by the European Medicines Agency for nAMD and DME, and submissions to other regulatory authorities around the world are ongoing.
It is the first bispecific antibody for the eye and the only injectable eye drug approved in a number of countries for treatments up to four months apart.
According to Roche, the drug is designed to block two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). .
“While research is ongoing to better understand the role of the Ang-2 pathway in retinal disease, both Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which can lead to the formation and increase of new leaky blood vessels. inflammation,” the company said.
New anti-VEGF therapies seeking Australian approval
Anti-VEGF remains the most expensive PBS drug