CSL Vifor Says FDA Grants Partner American Regent Approval For Injectafer To Treat Iron Deficiency

RTTNews | 709 ngày trước
CSL Vifor Says FDA Grants Partner American Regent Approval For Injectafer To Treat Iron Deficiency

(RTTNews) - Swiss pharma firm CSL Vifor, a subsidiary of Australia's CSL Ltd. (CSL.AX, CSLLY.PK), announced Monday that the U.S. Food and Drug Administration (FDA) has granted its partner American Regent, Inc., a Daiichi Sankyo Group company, approval for Injectafer for the treatment of iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity.

CSL Vifor has granted American Regent an exclusive right to develop, manufacture and market Injectafer in the United States.

The FDA approval was supported by CSL Vifor's randomized placebo-controlled study, CONFIRM-HF (NCT01453608), which evaluated the efficacy and safety of ferric carboxymaltose in adult patients with symptomatic heart failure and iron deficiency.

The treatment over a 1-year period resulted in a significant and sustainable improvement in exercise capacity in this patient population.

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CSL Behring Says HEMGENIX Receives Positive Canada Reimbursement Decision

CSL Behring Says HEMGENIX Receives Positive Canada Reimbursement Decision

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Malaysia Bourse May See Additional Support

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Mild Rebound Tipped For Japan Stock Market

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Win Streak May Continue For South Korea Shares

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Australia Unemployment Data Due On Thursday

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RTTNews | 1h 36phút trước
European Markets Close With Mild Losses

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Swiss Franc Weakens Against Majors

Swiss Franc Weakens Against Majors

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RTTNews | 3h 33phút trước