FDA kicks off review of Roche's Gazyva for wider lupus use

Roche could be just months away from an FDA approval of Gazyva as the first anti-CD20 therapy for systemic lupus erythematosus (SLE), a debilitating autoimmune disease affecting millions of people around the world.

Already approved for SLE patients who have a serious inflammation of the kidneys known as lupus nephritis in the US and Europe, Gazyva (obinutuzumab) – which is sold as Gazyvaro in some markets – is now under FDA review as a treatment option for all SLE patients.

Around half of people living with SLE will develop lupus nephritis within five years, so, extending Gazyva's use into the wider SLE population could lead to earlier use of the drug and, potentially, prevent patients from developing kidney complications.

The FDA will cast its eyes over the results of the ALLEGORY trial, which revealed that treatment with Gazyva was associated with a significant reduction in disease activity compared with placebo, measured using the SLE Responder Index 4 (SRI-4) scale at 52 weeks, when added to standard therapy like corticosteroids and immunosuppressant drugs.

An SRI-4 response was observed in 76.7% of the patients in the Gazyva group and in 53.5% of the control group, and the anti-CD20 therapy also scored significantly better on secondary endpoints, looking at the time to the first flare in symptoms and the ability to taper steroid use.

Roche has said that the results of the 303-patient study, published in the New England Journal of Medicine last month, could position Gazyva as the new standard of care for SLE. The drug has also been submitted for approval in the EU as an SLE therapy.

"For people living with SLE, the daily challenges of the disease can be both physically and emotionally overwhelming," said Albert T Roy, president and chief executive of the Lupus Research Alliance.

"We are hopeful for the approval of Gazyva as a new treatment for SLE, given its potential to manage symptoms, as well as drive higher rates of clinical remission and reduce the frequency of debilitating flares."

If approved, it will join other biologic therapies for SLE, which include GSK's BLyS inhibitor Benlysta (belimumab), which grew 26% to nearly $2.4 billion last year, and AstraZeneca's type I interferon receptor antagonist Saphnelo (anifrolumab), which brought in $686 million, a rise of 44%.

Roche recorded around $1.26 billion in Gazyva sales for the drug last year, and analysts at GlobalData have previously said that approval for SLE could help drive sales to $1.7 billion or more by the end of the decade.

Other therapies for lupus and its complications are coming through the industry pipeline, including Johnson & Johnson's FcRn blocker nipocalimab, Biogen's BDCA2-targeted litifilimab and anti-CD40L antibody dapirolizumab pegol (DZP), and Merck KGaA's oral TLR7/8 inhibitor enpatoran, all of which are in late-stage clinical testing.