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GCA is an autoimmune disease that causes inflammation of the temporal and other cranial arteries, the aorta, and other large and medium arteries. GCA generally impacts patients older than 50 years, most commonly between the ages of 70 and 80 years. ³

“The EC approval of RINVOQ in GCA provides patients and physicians with a new treatment option and the first oral advanced therapy for adults living with GCA – a particularly vulnerable population due to older age and frequent comorbidities,” ^3,4 said Roopal Thakkar , M.D., executive vice president, research & development, chief scientific officer, AbbVie. “This exciting milestone demonstrates our commitment to ongoing research and expanding indications in areas of high unmet need to help patients achieve better outcomes, including sustained disease remission.”

The EC approval is supported by data from the Phase 3 SELECT-GCA trial, which was recently published in the New England Journal of Medicine . ¹ In this trial, primary and key secondary endpoints were achieved with RINVOQ 15 mg and a 26-week steroid taper regimen compared to placebo in combination with a 52-week steroid taper regimen. ¹

Primary endpoint results from the Phase 3 SELECT-GCA trial demonstrated:

• Sustained remission * : 46.4% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission at week 52, compared with 29.0% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.002). ¹

Key secondary endpoints included:

• Reduction in disease flares: 34.3% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen experienced at least one disease flare through week 52 versus 55.6% of patients receiving placebo in combination with a 52-week steroid taper regimen (p=0.001). ¹
• Lower cumulative steroid exposure: Through 52 weeks, cumulative steroid exposure was significantly lower for patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen than for patients receiving placebo in combination with a 52-week steroid taper regimen (median exposure of 1615 mg versus 2882 mg, respectively; p 1
• Sustained complete remission ^† : 37.1% of patients receiving RINVOQ 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remission through week 52, compared with 16.1% of patients receiving placebo in combination with a 52-week steroid taper regimen (p 1

During the 52-week, placebo-controlled period, the safety profile of RINVOQ was generally consistent with that observed in other approved indications. ² Similar rates of serious adverse events were observed in patients receiving RINVOQ 15 mg and in those receiving placebo. ¹ Serious infections occurred in 5.7% of the RINVOQ 15 mg group and 10.7% of the placebo group. ¹ The proportions of patients with events of interest were balanced across treatment groups for incidence of malignancy (excluding…