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Lilly and Boehringer's Jardiance reduces hospitalisation and CV death risk from heart failure at Phase 3

Boehringer Ingelheim and Eli Lilly have announced strong Phase 3 news on their sodium-glucose co-transporter-2 (SGLT2) inhibitor Jardiance (empagliflozin) in the treatment of adults with heart failure with reduced ejection fraction, with and without diabetes.

The pair revealed that the 10mg dose of the drug met its primary endpoint in a study of 3,630 participants, successfully reducing the risk of cardiovascular death or hospitalisation as a result of heart failure when used in combination with standard of care.

FDA turns down label expansion for Jardiance as an adjunct to insulin in type 1 diabetes

The FDA has chosen not to approve an expanded indication of 2.5mg Jardiance (empaglifozin) as an adjunct to insulin in the treatment of type 1 diabetes.

The decision follows a recommendation in November 2019 from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) not to approve the therapy. The committee voted 14-2 against, arguing that the 2.5mg dose did not present an adequate benefit/risk profile as an adjunct to insulin.

FDA advisory committee votes down approval of Boehringer and Lilly's drug for type 1 diabetes

Boehringer Ingelheim and Eli Lilly’s have been dealt a blow from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), after the independent panel voted against the use of the pair’s SGLT2 inhibitor empagliflozin (branded as Jardiance) as an add-on insulin therapy in the treatment of type 1 diabetes.

The drug is already approved, with the FDA passing approval in 2014 for the reduction of blood sugar levels in type 2 diabetes patients.

FDA approves another indication for Lilly/Boehringer diabetes treatment

Jardiance (empagliflozin), an oral SGLT02 inhibitor developed by Eli Lilly and distributed by Boehringer Ingelheim, has been approved by the FDA for an expanded indication, increasing the drug’s applications to include the reduction of risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease.

Eli Lilly says FDA panel backs approval of Jardiance for cardiovascular indication

US drugmaker Eli Lilly (NYSE: LLY) said a US regulatory panel has backed its Jardiance (empagliflozin) for reducing cardiovascular death in adults with type 2 diabetes and heart condition.

The company said the US Food and Drug Administration advisory committee voted 12-11 in favour odf the drug. Jardiance, which is marketed by Boehringer Ingelheim and Eli Lilly is the only oral type 2 diabetes medicine shown in a clinical trial to reduce the risk of cardiovascular death.

Lilly and Boehringer Ingelheim to evaluate diabetes drug for treatment of heart failure

Eli Lilly (NYSE: LLY) and Boehringer Ingelheim have announced plans to conduct two outcome trials evaluating diabetes medicine Jardiance (empagliflozin) for the treatment of chronic heart failure.

Jardiance was the first diabetes treatment to demonstrate a reduction in the risk of cardiovascular (CV) death in a dedicated CV outcomes trial. The new trials are targeted to begin within the next 12 months and are planned to enrol people with chronic heart failure both with and without diabetes.

FDA reviews Jardiance as cardiovascular diabetes treatment

Jardiance

The FDA has accepted Boehringer Ingelheim and Eli Lilly’s supplemental New Drug Application for their diabetes drug Jardiance to be used to help reduce the risk of cardiovascular death in patients with type 2 diabetes.

NICE recommends Velcade for MCL, and three diabetes drugs

Janssen Velcade

NICE has published final guidance recommending Velcade (bortezomib) as a treatment for previously untreated mantle cell lymphoma (MCL). 

In the Phase III LYM‑3002 trial Velcade, in combination with rituximab, cyclophosphamide, doxorubicin and prednisone (VR‑CAP), was shown to extend progression free survival (PFS) by 10.3 months compared to rituximab with cyclophosphamide, doxorubicin, vincristine and prednisone (R‑CHOP). Patients in the VR-CAP arm had a median PFS of 24.7 months, compared to 14.4 months for those treated with the R-CHOP combination.

Jardiance scores more cardiovascular outcomes data

Boehringer Ingelheim and Lilly co-market Jardiance for type 2 diabetes

A sub-group analysis of data from an outcomes study of Boehringer Ingelheim’s and Lilly’s Jardiance has found the diabetes drug reduces the risk of heart failure outcomes by 39%.

Earlier this year the two companies in the diabetes alliance presented preliminary data from the EMPA-REG OUTCOMES trial, which was the first to find that a blood sugar-lowering drug could reduce the risk of cardiovascular events.

More positive CV data for Boehringer and Lilly’s Jardiance

Jardiance

Jardiance, an anti-diabetes drug produced by Boehringer Ingelheim and Eli Lilly, reduces the risk of death in people with type 2 diabetes, according to the results of a Phase III study.

The results of the EMPA-REG OUTCOME trial found Jardiance (empagliflozin) had a statistically significantly 14% lower rate of the primary outcome – death from cardiovascular causes – when the study drug was added to standard care, compared to treatment with standard care alone.

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