Sunday, 21 July, 2024
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FDA approvals this week: Drugs for cholesterol, migraine, and CVD in type 2 diabetes

US regulators have approved a new type of cholesterol-lowering drug aimed at millions of people who can’t tolerate – or don’t get enough help from widely used statin pills like Lipitor and Crestor, reports AP News.

The US Food and Drug Administration (FDA) approved Esperion Therapeutics Inc’s Nexletol for people genetically predisposed to have high cholesterol and people who have heart disease and need to further lower their bad cholesterol. The daily pill is to be taken in conjunction with a healthy diet and the highest statin dose patients can handle, the FDA said.

“This is a nice alternative” to statins, but those medicines will still be the first choice, said Dr Christie Ballantyne, Baylor College of Medicine’s cardiology chief. He consults for Esperion and helped test the drug.

The new drug “would be valuable to add to treatment” for patients who can’t get their LDL down enough with existing drugs or can’t afford the injected ones, Duke Heart Centre co-director Dr Manesh Patel said. Patel, who was not involved in the research, estimated 10% to 15% of his patients might be eligible for Nexletol.

The report says in company-funded studies, common Nexletol side effects included high blood pressure and muscle and joint pain. Serious side effects include tendon rupture. Women who are pregnant or breast-feeding should not take Nexletol because of possible harm to the baby, the FDA said.

The FDA has also approved Lundbeck’s migraine prevention therapy. Reuters Health reports that Lundbeck’s Vyepti belongs to a class of drugs called monoclonal antibodies (mAb) that are laboratory-produced molecules engineered to serve as substitute disease-fighting antibodies.

Vyepti, also known as eptinezumab, inhibits calcitonin gene-related peptide (CGRP), which plays a key role in causing migraine pain. Eptinezumab is administered through a 30-minute IV infusion.

The report says the top three leading CGRP inhibitors from Amgen Inc, Eli Lilly & Co and Teva Pharmaceuticals Industries are all administered by injections.

Eli Lilly and Co has announced, meanwhile, that the FDA has approved Trulicity for reducing cardiovascular risk factors in type 2 diabetic patients.

Reuters Health reports that the company said the approval makes Trulicity the first and only type 2 diabetes drug approved to reduce heart related risks in adults with and without established cardiovascular disease.

[link url="https://apnews.com/528e7e964a18429240638fcf2308bd1d"]Full AP News report[/link]

[link url="https://www.reuters.com/article/us-h-lundbeck-fda/fda-approves-lundbecks-migraine-prevention-therapy-idUSKBN20G02D"]Full Reuters Health report[/link]

[link url="https://www.reuters.com/article/us-lilly-fda/fda-approves-eli-lillys-trulicity-to-reduce-cardiovascular-risks-in-type-2-diabetic-patients-idUSKBN20G02L"]Full Reuters Health report[/link]

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