Switzerland OK’s Tavneos as Add-on Therapy for GPA, MPA

Swissmedic approval follows ADVOCATE trial, which tested therapy on 331 AAV patients

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by Steve Bryson, PhD |

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Tavneos (avacopan) has been approved as an add-on therapy for adults in Switzerland with severe, active microscopic polyangiitis (MPA) or granulomatosis polyangiitis (GPA), the two main types of ANCA-associated vasculitis (AAV).

Following the decision by the Swiss Agency for Therapeutic Products, Swissmedic, the launch of Tavneos is expected soon after details are finalized with the Federal Office of Public Health, the Swiss federal government’s center for public health. As an add-on treatment it would be used alongside rituximab or cyclophosphamide.

“This is a significant step forward for patients in Switzerland living with this systemic condition,” Alfred Mahr, MD, PhD, a senior rheumatologist at the Cantonal Hospital St. Gallen, in Switzerland, said in a press release. “We are confident that this long-awaited new class of medication has the potential to better manage the disease and overall treatment burden, meeting major unmet medical needs in the treatment of ANCA-associated vasculitis.”

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Lung, ENT Involvement, Steroid Use Reduced With Tavneos: ADVOCATE

Tavneos is an oral therapy designed to reduce inflammation and damage to small blood vessels caused by an overactive complement system, a group of immune-related proteins that trigger autoimmune attacks in people with AAV.

The approval was supported by data from the Phase 3 ADVOCATE trial (NCT02994927), which evaluated the therapy in 331 AAV patients across 20 countries.

The study’s main goal was to find out whether Tavneos could replace standard glucocorticoids, such as prednisone, in AAV treatment regimens. Glucocorticoids are commonly used with other AAV therapies, but their long-term use can lead to harmful side effects.

Trial data showed Tavneos reduced disease activity after about a year of treatment and was more effective than prednisone at improving kidney function in those with severe kidney impairment.

ChemoCentryx, which is being acquired by Amgen, initially developed Tavneos in the U.S., where it owns the therapy’s commercial rights. Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has the rights to sell Tavneos outside the U.S.

“We are very excited about the authorization of Tavneos for the adjunctive treatment of ANCA-associated vasculitis in Switzerland,” Jörg Storre, general manager of CSL Vifor, VFMCRP’s joint company in Switzerland, said. “This will allow us to bring an innovative medicine and a new treatment option with the potential to improve the standard of care to patients living with this systemic and severe disease.”

“Our teams are committed to collaborating with the Federal Office of Public Health, healthcare professionals and our partners to ensure access to Tavneos for patients in Switzerland,” Storre said.

Swissmedic has also granted orphan medicinal product status for Tavneos as an add-on treatment for MPA and GPA. This designation is available to medicinal products that prevent or treat life-threatening or disabling diseases affecting fewer than 5 out of 10,000 people in Switzerland and provides financial support to its developers.

The therapy’s latest approval follows similar rulings in the U.S., Canada, the European Union, Great Britain, and Japan.