Boehringer Ingelheim gets CDSCO panel nod to market Jardiance for additional indication

New Delhi: In a significant development, drug-major Boehringer has got a go ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) to market its popular diabetes drug empagliflozin for an additional indication to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure and reduced ejection fraction in adults.

This nod came after the firm presented the USFDA approval details for Empagliflozin Tablets 10/25mg as a new indication to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure and reduced ejection fraction, in light of the SEC recommendation dated 09.03.2021 and 10.03.2021.

Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitus.

JARDIANCE is the first type 2 diabetes treatment approved with this additional indication and the only oral type 2 diabetes medicine shown in a clinical trial to provide a life-saving cardiovascular benefit. JARDIANCE is marketed by Boehringer Ingelheim and Eli Lilly and Company.

In 2016, the U.S. Food and Drug Administration (FDA) approved a new indication for Jardiance (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

In continuation, this year in August, Boehringer Ingelheim and Eli Lilly and Company announced that Jardiance (empagliflozin) 10 mg has been approved by the U.S. Food and Drug Administration to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure with reduced ejection fraction (HFrEF).

"This approval for Jardiance is based on results from the EMPEROR-Reduced phase III trial, which investigated the effect of adding Jardiance 10 mg versus placebo to standard of care in a broad range of 3,730 adults with and without type 2 diabetes who had heart failure (functional class II, III or IV) and a left ventricular ejection fraction of 40% or less. In the trial, Jardiance significantly reduced the relative risk of the primary composite endpoint of time to cardiovascular death or hospitalisation for heart failure by 25% (5.3% absolute risk reduction, 0.75 HR, 0.65-0.86 95% CI) versus placebo. These results were seen regardless of background heart failure standard of care treatments, "the drug major, Boehringer Ingelheim, stated in the release.

Earlier, at the 85th SEC meeting for Cardiovascular and Renal held on 09.03.2021 & 10.03.2021, the pharma-major Boehringer Ingelheim India presented their proposal for Empagliflozin Tablets 10mg/25 mg before the committee for additional indication.

In response, at the earlier meeting the committee recommended the grant of permission for indication,

1.Heart failure

2. Empagliflozin tablets are indicated in adult patients with heart failure (NYHA class II-IV) and to reduce ejection fraction with or without type 2 diabetes mellitus;

In addition, the firm was directed that for the approval of other indications applied by the firm, the firm is required to submit more clinical data to consider the matter further.

Accordingly, at the recent SEC meeting, the expert panel extensively evaluated the USFDA approval details for Empagliflozin Tablets 10/25mg as a new indication presented by drug-major Boehringer.

After detailed deliberation, the committee recommended the grant of permission for marketing the drug for an additional indication to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure and reduced ejection fraction.

The committee also opined that the proposal for the update of the package insert should be deliberated separately.