Roche bags FDA Breakthrough for Gazyva in lupus nephritis
pharmafile | September 18, 2019 | News story | Research and Development | FDA, Gazyva, Roche, lupus nephritis
The US FDA has granted Breakthrough Therapy Designation to Gazyva (obinutuzumab) for adults with lupus nephritis.
The win comes on the back of from data from its phase 2 NOBILITY trial with showed that Gazyva, in combination with standard of care, demonstrated enhanced efficacy compared to placebo plus standard of care alone in achieving a complete renal response at one year.
Gazyva was approved by the FDA for lymphoma in 2013 and again for follicular lymphoma in 2016.
Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, said: “new treatment options are needed for lupus nephritis, a potentially life threatening inflammation of the kidneys that most commonly affects women.
“We are committed to developing Gazyva as a potential new therapy for lupus nephritis and plan to begin enrolling patients in a Phase 3 trial next year.”
The phase 2 study NOBILITY utilised 126 people who were randomised to receive Gazyva or placebo infusions on certain days over the course of 52 weeks.
Lupus nephritis is a severe and potentially life-threatening disorder of the kidneys and it is estimated it affects 24 per 100,000 in the global population. Up to 25% of people with the condition develop end-stage renal disease.
Breakthrough Therapy Designation is designed to accelerate the development and review of medicines intended to treat serious or life-threatening conditions with preliminary evidence that indicates they may demonstrate a substantial improvement over existing therapies.
In all, this amounts to the 27th Breakthrough Therapy Designation for Roche’s portfolio of medicines.
Nik Kiran
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