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AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

It is claimed to be the first anti-inflammatory atheroprotective cardiovascular treatment to receive approval from the regulator. The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

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FDA Approves Treatment for Wider Range of Patients with Heart Failure

The Pharma Data

Jardiance is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease, and to reduce the risk of death and hospitalization in patients with heart failure and low ejection fraction. Source link: [link].

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Top 15 Diabetes Drugs in 2023 by 2022 Sales Statistics

XTalks

Ozempic (Semaglutide) Ozempic sales in 2022: $8.713 billion Company/Developer: Novo Nordisk Date of first FDA approval: December 5, 2017 Indications Ozempic is FDA-approved for: Type 2 diabetes Price of Ozempic: $1,029 for 1.5 Read on to learn more about the top 15 diabetes drugs in 2023, based on 2022 sales statistics.

Sales 52
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Jardiance gets parity with Farxiga in US as FDA clears use in heart failure

pharmaphorum

Eli Lilly and Boehringer Ingelheim have claimed FDA approval for their diabetes therapy Jardiance in heart failure with reduced ejection fraction (HFreF), setting up a market tussle with AstraZeneca’s Farxiga. The post Jardiance gets parity with Farxiga in US as FDA clears use in heart failure appeared first on.

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Boehringer, Lilly’s Jardiance ties to match AZ’s Farxiga with heart failure label

pharmaphorum

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabetes. Farxiga won FDA approval for adults with HFrEF in May 2020, which helped to drive its third-quarter sales up by a third to $525 million.

Sales 76
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Agent Drug-Coated Balloon: A New Era in Coronary In-Stent Restenosis Treatment

XTalks

The FDA’s approval is based on positive results from the AGENT IDE trial , a multicenter, prospective, randomized controlled study, which demonstrated the statistical superiority of Agent DCB over uncoated balloon angioplasty in preventing target lesion failure (TLF) at 12 months.

Drugs 52
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Farxiga faces first heart failure rival as EU OKs Boehringer/Lilly’s Jardiance

pharmaphorum

AstraZeneca’s SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly’s rival therapy Jardiance. . billion respectively, assuming they also get approved for the HFpEF indication.

Sales 98