NEW YORK (CNNMoney.com) - AstraZeneca, the pharmaceutical group, will soon be asking U. S. regulators to investigate whether the drug's patent for a statin can be reclassified, the company said Tuesday.
The move comes amid a controversy over patents in the United States for statin drugs and other drugs used to lower cholesterol and reduce cardiovascular risk.
The FDA has been weighing whether statins are safe for use in people with high cholesterol or other risk factors, the company said. It's unclear how much of a revenue tax AstraZeneca has been looking for and what kind of drug will be subject to the reclassification.
The company said it was reviewing the reclassification in a recent regulatory hearing that was scheduled for Jan. 18.
The FDA is evaluating the reclassification of two statins that were once used for the treatment of high cholesterol in adults. AstraZeneca said the drugs are approved for use as a cholesterol-lowering medication and not for prevention.
"These two approvals have been pending approval in a number of different FDA clinical trials and will be reviewed by the FDA and other pharmaceutical companies, including AstraZeneca and Teva Pharmaceuticals Corporation, in order to determine if the two drugs have the same safety profile," AstraZeneca said in a statement.
The FDA said it was taking steps to ensure that the reclassification of two statins is not impacted by the drug approval.
In December, the FDA recommended that doctors prescribe a new drug for a condition called "prostate cancer," which can lead to serious health problems. The agency also recommended that doctors prescribe a new drug for a disorder called "stomach ulcers" which can affect a person's digestive system.
AstraZeneca said Tuesday that it has been evaluating the reclassification of two statins, one used to lower cholesterol and one used to reduce the risk of heart attacks and strokes.
"We believe that these two drugs are safe and effective in a majority of patients, and that this reclassification will require further clinical evaluation and approval," AstraZeneca said in a statement. "We will continue to work closely with our U. and Canadian regulatory agencies and the Food and Drug Administration to evaluate these drug approvals and determine the appropriate regulatory actions."
In addition, AstraZeneca said its drugs are being evaluated for safety and effectiveness, and that a ruling from the FDA would likely be final.
AstraZeneca's patent for the drug had expired in 2010, but U. regulators have since said they have also granted patents to other companies with the same drug's active ingredient.
The company said that it plans to make a decision in its first round of litigation in the United States against AstraZeneca in December, or a potential settlement.
The pharmaceutical giant has also said it will pursue litigation against two other companies, including Merck & Co, which sells drugs for heart disease and cholesterol, and Pharmacia, which sells drugs to treat cancer and diabetes, among other drugs.
The companies have argued that they have a patent on the cholesterol-lowering drug Crestor, which was previously known as Crestor. The FDA had initially rejected Crestor, saying that it was a potentially harmful compound.
The companies have also settled a class action lawsuit, which was filed by a group of about 1,300 people who claim they suffered from heart disease.
The settlement comes after a trial in which the two companies said they are working with the U. Food and Drug Administration to make an appeal of the decision.
David A. Bothwell analyst Sander Lund said the case is unlikely to go to trial because the FDA had not approved Crestor."We believe it's going to be a long-term issue, but it's not that we're worried about it," said Lund, a analyst at Deutsche Bank.
The case is AstraZeneca's second in a series of lawsuits over a compound known as Crestor, which is marketed as a treatment for high cholesterol and other cardiovascular diseases. The drug was approved by the FDA in 2004.
Originally Published: July 3, 2013 at 6:00 AM EDT
Bothwell analyst Sander Lund said the case is unlikely to go to trial because the FDA had not approved Crestor, which is known to interact with the drug."There is not enough evidence that it would interact with Crestor," said Lund. "If there is, I think we have to wait and see.
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Crestor, containing rosuvastatin, is a widely prescribed statin medication for managing cholesterol levels. It lowers LDL (bad cholesterol) and triglycerides while raising HDL (good cholesterol), reducing the risk of cardiovascular complications such as heart attacks and strokes. It is a trusted choice for individuals at risk of heart disease or those with high cholesterol.
Benefits of Crestor:
Dosage:
Warnings and Precautions:
Usage Instructions:
Storage Information:
Common Side Effects:
More information about Crestor:
See also:FAQs of Crestor:Crestor is an effective cholesterol-lowering medication for many individuals. It lowers bad cholesterol and triglycerides, improving blood circulation to the organs and facilitating overall cholesterol management.
Crestor is not suitable for women, especially during pregnancy, as it can cause fetal harm. Consult with your doctor if you have cardiovascular disease, liver disease, kidney disease, or other underlying medical conditions. Crestor may not be suitable for you if you are allergic to Crestor or any of its ingredients.
Crestor is not suitable for individuals with a history of heart problems, including heart failure, or those taking atorvastatin. Consult with your doctor if you have any rare and serious health conditions such as severe vision loss, severe liver disease, severe heart failure, diabetes, or a history of drug or medical complications of cardiovascular disease or liver disease.
Patients should discuss their cholesterol levels with their doctor to determine the most appropriate treatment option.
Crestor works by reducing a certain enzyme within the body that produces cholesterol. It belongs to a class of medications called statins.
Cholesterol is a form of lipid, a waxy substance that helps your body make cells, vitamins, and certain hormones. It is not inherently bad. Your liver produces an enzyme that synthesizes cholesterol to help with the above healthy functions. Additional cholesterol is introduced to the body through certain foods like meat, poultry, and dairy products.
There are two types of cholesterol: high-density lipoproteins (HDLs) and low-density lipoproteins (LDLs). LDLs carry cholesterol throughout the body, delivering cholesterol to cells that need it. HDLs carry excess LDLs back to the liver, where they are broken down and flushed from the body. While LDLs play a key role in cell health, they build up when the body has more cholesterol than the cells need. This buildup turns into plaque in the arteries (blood vessels). As plaque covers the artery walls, the blood vessels become narrow. This makes it harder for blood to flow through the body, which can lead to heart disease and heart failure.
Statins work by reducing the production of cholesterol in the liver, which lowers the overall cholesterol levels in the body. Not only do statins decrease levels of LDLs in the body, but they can also raise the level of HDLs in the body. In effect, they keep the body from making too much of the “bad” cholesterol that builds up in arteries while increasing the amount of “good” cholesterol that carries the “bad” out of the body. This dual action has been shown, along with diet and exercise, to lower overall cholesterol levels in patients effectively.
Crestor tabletsHow to Take a Crestor TabletThe recommended starting dose of a statin is approximately half of the dose that the bacteria was taken from. The other higher dose dose is chosen to minimize the risk of side effects. Take the dose that your doctor has prescribed you, and then take the next dose at the lowest dose that works best for you. Do not increase the dose or stop taking a dose more than once a day; consult your doctor for a controlled increase in dose. A dose of 20 milligrams is a dose that your doctor has prescribed you in advance. Your doctor may change the dose of a dose of medicine based on how you respond to the dose they have prescribed you.
Your doctor may change the dose of a dose of medicine based on how you respond to the dose they have prescribed you in advance. It is important to take a 20 milligram dose of medicine at the same time each day to maintain optimal absorption of the medication. Do not increase or decrease the dose of 20 milligrams or dosage it is recommended to take per day or per week.
Swallow the tablet whole with water. Do not chew or crush the tablet. Swallow the tablet whole with water. Taking a 10 milligram or 20 milligram dose of a statin tablet can cause a blood pressure that is too low for you to get an adequate level of cholesterol from your blood. This can lead to a fast heartbeat, loss of appetite, and nausea.
A 10 milligram dose of a statin tablet can cause a high potassium blood pressure that is too high for you to get any result from from taking it. This can lead to low blood pressure, high cholesterol, or death.
A 10 milligram dose of a statin tablet can cause a high cholesterol blood level that is too high for you to get any result from taking a lower dose of a dose of a statin tablet. This can lead to low blood cholesterol, heart disease, or death.
Dr. O’Neill recommends taking a 10 milligram dose of a statin tablet at the same time each day for optimal effectiveness. This dose of a statin should not be taken more than once a day; your doctor will determine the maximum dose you will need to lose weight and should talk to you about the best dose for you.
A 10 milligram dose of a statin tablet can also cause a high potassium blood pressure that is too high for you to get any result from taking a 10 milligram dose.
If you are taking a medicine that contains a nonsteroidal anti-inflammatory drug (NSAID), you may be prescribed a higher dose of a medicine that contains one or more of the other ingredients of this medication.
You should not take a higher dose of a medication than the recommended starting dose.
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