Roche’s Gazyva has won Breakthrough Therapy status for its potential new use in the autoimmune disease lupus nephritis, as the Swiss pharma attempts to breathe new life into the drug currently approved in leukaemia and lymphoma.
Gazyva (obinutuzumab) works by targeting CD20, a protein only found in B-cells that cause leukaemia and lymphoma, and become abnormally stimulated in patients with Lupus.
With sales of around $240 million in the first half of the year, Gazyva (obinutuzumab) is currently one of Roche’s also-ran drugs, with its revenues being only a fraction of those achieved by its big cancer drugs.
But Roche thinks it has untapped potential as Gazyva has greater potency than its CD20-targeting cancer and inflammatory diseases blockbuster Rituxan in depleting B-cells in tissues and peripheral areas.
B-cells residing in tissues are thought to play a role in lupus nephritis, and they need to be completely depleted to fight the disease, Roche said in a briefing in its half-year results statement earlier this year.
While the Swiss pharma is also developing Gazyva in various other cancer combinations, the FDA agrees with Roche about its potential in lupus nephritis, where it has granted it Breakthrough Therapy status.
This tag is set aside for medicines that could represent a substantial improvement over standard therapies for serious conditions – and as there are no FDA-approved drugs for lupus nephritis there is a need for progress in the disease.
Following the results of the phase 2 NOBILITY study, the FDA will expedite development of the drug and potentially give a faster six-month review of data when it receives a filing in the new indication. Roche plans to bring phase 3 studies next year.
NOBILITY showed Gazyva, in combination with standard care (mycophenolate mofetil or mycophenolic acid and corticosteroids), outperformed standard care alone in adults with the disease in achieving complete renal response at one year.
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus resulting from inflammation of the kidneys and is associated with a high risk of end-stage renal disease or death.
Lupus affects 24 people per 100,000 population globally, and up to 60% of those develop lupus nephritis, and around a quarter of people with the condition develop end-stage renal disease.
Around 90% of people with the disease are women and it overwhelmingly affects women from African, Hispanic, and Asian ethnic groups who are two to three times more likely to be diagnosed with lupus than Caucasian women. Currently there is no cure for lupus or lupus nephritis…