Researchers on Monday are slated to release the full data from a Phase II study of REGN 727, which Regeneron is developing in partnership with French drugmaker Sanofi. The findings will better enable investors to size up the pros and cons of the rival therapies.
Neither drug has so far shown any serious side effects in clinical trials.
GETTING EVERYONE TO GOAL?
Dias said the ability of drugs like AMG 145 to slash LDL beyond decreases attributed to statins such as Pfizer Inc’s Lipitor could help enable millions of heart patients to finally get their cholesterol levels tightly controlled.
Food Selections Can Help Lower LDL or “Bad” Cholesterol
Here are some easy ways to do that:
- Use only nonfat or lowfat dairy products, including milk, yogurt and cheese. Regular dairy products, such as whole milk, butter, cheese, cream cheese and ricotta cheese, are high in saturated fat.
- Limit the amount of saturated fat. No more than 5 percent of your daily calories should come from saturated fat. That’s about 10 to11 grams a day for most people. One tablespoon of butter has 7 grams of saturated fat; a tablespoon of margarine has only 2 grams of saturated fat.
- Avoid foods with added trans-fat. This fat comes from partially hydrogenated vegetable oils often found in fried foods and processed foods such as crackers, baked goods and desserts.
- Base most of your meals on beans, vegetables, fruits and whole grains, with a minimum of low saturated fat foods from animal protein such as nonfat dairy, fish and egg whites.
- Include soy protein in your diet in place of animal protein when possible. Studies show that 25 grams of soy protein per day can help lower cholesterol when part of a heart-healthy diet.
- Limit intake of sugar and fructose. Doing so should lower triglycerides, aid weight loss and lower LDL cholesterol levels.
- Eat foods naturally high in fiber, especially soluble fiber. Soluble fiber is found in legumes, fruits and root vegetables, as well as oats, barley and flax. For every 1 or 2 grams of soluble fiber you eat daily, you lower LDL cholesterol levels by 1 percent.
“A good 60 percent of high-risk patients in the United States are unable to meet their aggressive goals of getting LDL levels down” to target levels, Dias said, making them prime candidates for AMG 145 if it continues to do well in trials and is approved.
Steven Nissen, head of cardiology at the Cleveland Clinic, said anti-PCSK9 drugs, when used with statins, could eventually have a profound impact.
“If these drugs come to market, just about everyone with High cholesterol will be able to get to goal,” Nissen said, with the possible exception of “several hundred” people with rare genetic conditions that would not benefit.
Industry analysts says PCSK9 inhibitors, if approved, could generate annual sales approaching $20 billion.
Nissen cautioned, however, that larger trials are needed to assess the safety of AMG 145 and REGN 727. He said a big question that remains is whether U.S. regulators would approve the drugs without first requiring major studies that evaluate long-term heart attack and stroke risk.
“That’s the subtle wrinkle here,” said Nissen, who speculated the U.S. Food and Drug Administration might be willing to approve them without such costly outcomes trials because statins were approved without them on the basis of their ability to lower cholesterol.
Nissen said statins and the PCSK9 inhibitors, although different classes of medicines, both exert their influence on the LDL receptor - a protein that carries LDL cholesterol through the bloodstream.
“So one could argue that PCSK9 uses the same pathway as statins,” he said, a consideration that might score points with the FDA.
A four-week dosing schedule might be “modestly more attractive” to patients and doctors than injections every two weeks, Nissen said.
“But the frequency is not a make or break consideration,” he added, because patients would be able to inject themselves with the same types of tiny needles that are already widely used and accepted for other conditions, including diabetes.
By Ransdell Pierson