FDA Approvals Roundup: Korsuva, Jardiance, Xarelto

RoundupsRoundups | 25 August 2021 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Korsuva okayed for treating moderate-to-severe pruritus in hemodialysis patients
Cara Therapeutics’ Korsuva (difelikefalin injection) has been approved for treating moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
Approval of Korsuva was based on findings from two randomized, multicenter, double-blind, placebo-controlled trials — KALM-1, conducted in the US, and the global KALM-2  — as well as supportive data from an additional 32 clinical studies. A total of 851 patients from the indicated population received the study drug or placebo at the end of each hemodialysis session three times a week for 12 weeks. Itch intensity was established at baseline, and patients monitored and recorded itch intensity scores during the treatment period.
At 12 weeks, 40% of KALM-1 patients showed improvement from baseline of 4 or more points in itch intensity score, compared with 21% of placebo patients. In KALM-2, 37% of study drug patients had the same level of improvement, compared with 26% of placebo patients
The application was granted priority review and breakthrough therapy designation.
New indications
Jardiance nabs new indication for heart failure with reduced ejection fraction
Boehringer Ingelheim’s Jardiance (empagliflozin) has received a new indication for reducing risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction.
This latest indication marks Jardiance’s crossover from being a diabetes drug to being an effective cardiovascular therapy as well.
Jardiance was originally approved in 2014 for improving glycemic control in adults with type 2 diabetes. It received an expanded indication in 2016 for reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus with established cardiovascular disease.

The approval for Jardiance was based on findings from the randomized, double-blind Phase 3 EMPEROR-Reduced trial in which 3,730 adults with or without type 2 diabetes and a left ventricular ejection fraction of 40% or less were randomized to receive standard of care plus Jardiance or placebo. The composite primary endpoint was time to first event of cardiovascular death or hospitalization for heart failure. Median follow-up time was 16 months.
There was a significant reduction of 25% in relative risk of the composite endpoint in patients receiving Jardiance compared with placebo. The results were independent of the background heart failure standard of care treatments. A secondary endpoint analysis showed a significant 30% reduction of relative risk of first and recurrent hospitalizations for heart failure in the Jardiance patients compared with placebo patients.
Xarelto plus aspirin get new indication use in PAD patients post lower-extremity revascularization
Janssen’s Xarelto (rivaroxaban), combined with aspirin, has been granted an expanded indication for use in patients with symptomatic peripheral artery disease (PAD) who have recently undergone lower-extremity revascularization.
Approval of the direct oral anticoagulant was based on findings from the Phase 3 multicenter, randomized, double-blind, placebo-controlled VOYAGER PAD study in 6,564 patients from the indicated population. The study findings showed that Xarelto 2.5 mg twice daily with once-daily aspirin reduced the risk of adverse limb and cardiovascular events by 15%, compared with aspirin alone.
Xarelto was originally approved in 2011 to reduce risk of stroke and systemic embolism.
Opdivo extended for adjuvant treatment of urothelial carcinoma
Bristol-Myers Squibb’s Opdivo (nivolumab) has received a new indication for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection.
The approval for this indication was based on findings from the randomized, double-blind, placebo-controlled CHECKMATE-274 trial in patients from the indicated population. They were randomized to receive Opdivo or placebo until recurrence or unacceptable toxicity for a maximum treatment of up to 1 year. The primary efficacy endpoint was disease-free survival (DFS) in the intent-to-treat (ITT) population and in patients with tumors expressing PD-L1 of 1% or more.
In the ITT analysis, median DFS was 20.8 months in Opdivo patients, compared with 10.8 months in placebo patients. Median DFS was not reached in patients with tumors expressing PD-L1 of 1% who received Opdivo; patients who received placebo had a median DFS of 8.4 months.
The review used the Real-Time Oncology Review pilot program and the assessment and product quality assessment aids. The application was granted priority review for this indication.
Gvoke Kit gets expanded use for severe hypoglycemia in kids, adults
Xeris’s  Gvoke Kit (glucagon) has been approved in 1 mg/0.2 mL single-dose vial and syringe kit form as a ready-to-use rescue treatment for severe hypoglycemia in adults and children aged 2 years or older with type 1 diabetes.
The therapy is also available as an auto-injector (Gvoke HypoPen) and prefilled syringe (Gvoke PFS) for the same indication.
The approval for Gvoke Kit was supported by a pharmacokinetic study demonstrating bioequivalence of a 1-mg dose of Gvoke administered through a vial and syringe kit (Gvoke Kit) to the same dose administered as a prefilled syringe (Gvoke PFS).


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Tags: FDA, US

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