Today in London the FDA decided to postpone approval of a new experimental heart drug, seeking more information about the new product.
The drug called Certriad, combines AstraZeneca’s blockbuster cholesterol pill Crestor with Abbott Laboratories TriLipix.
According to Rueters,
The manufacturers said on Tuesday they had received a so-called “complete response letter” from the U.S. Food and Drug Administration for Certriad, which combines Astra’s blockbuster cholesterol pill Crestor and Abbott’s TriLipix.
Both companies said they were evaluating the letter from the agency and would respond to the request for additional information. An AstraZeneca spokesman declined to give further details.
Combo pills are fairly common for heart drugs, and most thought that FDA approval was a given. Merck merged Zocor and Zetia to form Vytorin, and soon they plan to combine Zetia with Pfizer’s Lipitor.
Combo pills are also fairly common in diabetes drugs. For example Januvia, Avandia,and Actos are all available as combo product with generic versions Glucophage.
In typical big pharma fashion, Astra did not disclose what the FDA has a problem with, but many analysts have voiced concern that Certraid does not have enough backing to pass FDA approval after the results from a clinical study this month showed there was no real benefit from adding TriLipix to Crestor.
According to a report recently released by the Institute of Medicine, hypertension (high blood pressure) has become the second leading cause of death for people in the US.
Although hypertension is easily preventable through diet, exercise and drugs, it claims one in six lives in the United States, costing our health care system upwards of 73 billion dollars this last year.
The committee chair David Fleming, who directs Public Health for Seattle and King County in Washington said
Hypertension as a disease is relatively easy to diagnose and it’s inexpensive to treat. Hypertension is really a neglected disease in this country. There’s a huge gap between what we could do and what we are doing.
Simply reducing salt and implementing a diet with more fruits, vegetables and lean protein could lower high blood pressure by as much as 22 percent, the Institute says.
Doctors typically use drugs like beta blockers (Lopressor, Toprol XL, Inderal) and ACE inhibitors (Captopril, Ramipril, Accupril) to control blood pressure. Lowering blood pressure can cut the risk of heart attack, stroke, heart failure as well as many other conditions.
The report went on to point out that 86 percent of people with uncontrolled high blood pressure have insurance, and see their doctors regularly. Flemming stated that doctors often fail to follow guidelines, which is why many patients do not know they have the condition and and take no steps to try and control it.
Don’t fall into this category, make sure to check with your doctor and make sure that your blood pressure is in a healthy range.
Of the many things that you may neglect, don’t allow your health to be one of them.
A new blood-pressure treatment has come on the market that is of potential interest to hypertension patients whose blood pressure is not being adequately controlled with monotherapy.
Last month, the US Food and Drug Administration (FDA) approved Novartis’ Valturna (aliskiren and valsartan), which combines in a single pill valsartan, the active ingredient in Diovan, the top-selling branded high blood pressure medicine and aliskiren, the active ingredient in Tekturna – the only approved direct renin inhibitor (DRI).
Valturna is the first and only medicine to target two key points within the renin system, an important regulator of blood pressure. It is suitable for patients whose high blood pressure has not been adequately controlled on aliskiren alone, or by an angiotensin receptor blocker, such as Diovan, alone. It could also be considered as an initial treatment for patients who are likely to need multiple drugs to achieve their blood pressure goals.
Valturna targets the renin angiotensin aldosterone system (RAAS) in two ways. The valsartan component blocks, at the receptor level, the action of angiotensin II, which causes blood vessels to tighten and narrow. The aliskiren component directly inhibits renin, an enzyme produced by the kidneys that starts a process that leads to formation of angiotensin II. This helps blood vessels relax and open.
Because Valturna combines two different types of blood pressure drug, it offers greater blood pressure reduction than either drug would alone. It also seems conceivable having both medications available in one pill would help consumers with drug costs and insurance coverage.
Cautions: Women of child-bearing age should be particularly careful with this medicine. AVOID USE IN PREGNANCY. Do not take if you are breastfeeding or if you are planning to become pregnant. If pregnancy is detected, discontinue Valturna as soon as possible. This is because drugs that act on the renin system can cause injury and death to the unborn baby. Other serious reactions to be aware of when taking Valturna are a risk of head and neck angioedema (a rapid swelling of the flesh), and hypotension (low blood pressure). If either of these are suspected, call your physican immediately. Side effects of Valturna are the same as those of its two component medications, valsartan and aliskiren. Patients may experience tiredness, sore throat, runny nose, diarrhea, upper respiratory tract infection, urinary tract infection, flu, or dizziness. Consult your doctor before taking this or any other medication.
-
Subscribe in a reader -
Ads
-
Medi-Share: Christian Health Insurance Alternative
Subscribe in a reader