Cholesterol Drug That Works Differently Than Widely Prescribed Statin Pills Approved By FDA

The Associated Press: FDA Approves Drug That Lowers Cholesterol In A New Way
U.S. regulators on Friday 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. The Food and Drug Administration approved Esperion Therapeutics Inc.’s Nexletol for people genetically predisposed to have sky-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. (Johnson, 2/21)

The Washington Post: FDA Approves Bempedoic Acid For High Cholesterol, The First Non-Statin Pill Introduced In Two Decades
The drug, bempedoic acid, is the first in a new class of drugs to treat low-density-lipoprotein cholesterol, also called “bad” cholesterol, which causes the buildup of fatty deposits in the arteries, reducing blood and oxygen flow. Cardiologists said the new drug, which is taken as a pill once a day, will be used primarily as an add-on therapy for people who are taking as high a dose of statin medications as they can tolerate but still have higher-than-desired cholesterol. Studies showed that bempedoic acid reduced cholesterol by an average of 18 percent in patients taking moderate- or high-dose statins, compared with the placebo group, said the manufacturer, Esperion Therapeutics. (McGinley, 2/21)

CNN: FDA Approves Non-Statin Drug To Treat High Cholesterol 
The FDA approved this drug based on the fact that it can lower cholesterol, but it’s still being studied to see if it will lower the risk of stroke and heart attack in patients who can’t tolerate statins. Nexletol works by inhibiting cholesterol production. Compared to a placebo, the drug reduced LDL cholesterol by an average of 18% in patients who were also on a statin, studies showed. The company has also applied for FDA approval to use the drug as a combination pill with ezetimibe, another non-statin. In studies, that combination reduced cholesterol between 38% to 44%, the company said. That FDA decision is expected soon. (Christensen, 2/24)

Stat: Esperion To Test Market For Cholesterol Pill Cheaper Than Some Competitors
Heart drugs have had a tough go of it in recent years. Repatha and Praluent, expected to be multibillion sellers, instead saw sales stagnate. Their makers took the unusual step of cutting the drugs’ prices by 60%. Entresto, a Novartis heart failure drug, had a slow start before sales took off. But now there is broadened interest. Amarin expects sales of its fish-oil-derived pill, Vascepa, of upwards of $650 million this year. And, early this year, Novartis spent $9.7 billion to buy The Medicines Company, which is developing a long-acting cholesterol lowering medicine. (Herper, 2/21)

In other pharmaceutical news —

Reuters: FDA Approves Lundbeck’s Migraine Prevention Therapy
The U.S. Food and Drug Administration approved Lundbeck A/S’ migraine prevention therapy, which the Danish drugmaker acquired through its near $2 billion deal for Alder BioPharmaceuticals in 2019, the company said on Friday. For Lundbeck, the approval opens doors to a lucrative but competitive market dominated by already approved rivals from Amgen Inc, Teva Pharmaceutical Industries Ltd and Eli Lilly and Co. (2/21)

Stat: With Data On Lead Drug, Kadmon And CEO Waksal Plot Their Redemption
Kadmon (KDMN), the New York-based biotech, is developing the first drug designed specifically to target chronic [graft-versus-host disease.] In new but still preliminary clinical trial results presented Sunday, the Kadmon drug, a pill called KD025, showed meaningful reductions of chronic GVHD in two-thirds of patients — nearly all of whom entered the pivotal clinical trial after current treatment options stopped working. (Feuerstein, 2/23)

The New York Times: At Walgreens, Complaints Of Medication Errors Go Missing
Pharmacy employees at Walgreens told consultants late last year that high levels of stress and “unreasonable” expectations had led them to make mistakes while filling prescriptions and to ignore some safety procedures. But when the consultants presented their findings at Walgreens’s corporate offices this month, there was no reference to the errors and little mention of other concerns the employees had raised. (Gabler, 2/21)

Kaiser Health News: Hormone Blocker Shocker: Drug Costs 8 Times More When Used For Kids
Dr. Sudeep Taksali, an orthopedic surgeon, became worried that his 8-year-old daughter had already grown taller than his 12-year-old son. And sometimes she had an attitude more befitting a teenager. Something seemed wrong. Taksali and his wife, Sara, realized their daughter had grown 7 inches in two years and was showing signs of puberty. They took her to the doctor, who referred her to a pediatric endocrinologist for a work-up. (Lupkin, 2/24)