British drug major AstraZeneca (AZN.L,AZN) announced Tuesday positive Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of moderate to severe systemic lupus erythematosus or SLE.
The company noted that Anifrolumab demonstrated superiority across multiple efficacy endpoints versus placebo, in patients with SLE .
Systemic lupus erythematosus is often difficult to treat, and innovative new therapies are urgently needed.
On the primary endpoint, the TULIP 2 results demonstrated that, by targeting the type I interferon receptor, anifrolumab reduces overall disease activity, reduces corticosteroid use and improves skin manifestations.
The TULIP 2 trial also showed statistically significant differences in multiple secondary endpoints.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said, “There has only been one new medicine approved for systemic lupus erythematosus in the last 60 years, which is why we are so excited to see the positive TULIP 2 results. There is now a strong body of evidence demonstrating the benefit of anifrolumab.”
TULIP 1 trial did not meet its primary endpoint based on the SLE Responder Index 4composite measure. However, analyses of secondary endpoints show efficacy consistent with TULIP 2 on BICLA response, reduction in OCS use, and improvement in skin disease activity.
AstraZeneca acquired global rights to anifrolumab through an exclusive license and collaboration agreement with Medarex, Inc. in 2004. Medarex was acquired by Bristol-Myers Squibb in 2009.
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