FDA Questions Who Should Take New Cholesterol Drugs
The drugs are said to represent the biggest advance in cholesterol-lowering treatment in 20 years. But there are still questions about long-term effects. In addition, the pricetags could limit those who benefit.
The Washington Post:
Could These New Cholesterol Drugs Save Many Americans From Heart Attacks?
A federal advisory committee this week will decide whether to recommend approval of the first in a new class of drugs many experts believe could significantly cut the risk of strokes and heart attacks, a leading cause of death for Americans. The highly-anticipated new drugs have been shown in clinical trials to sharply reduce levels of bad, or LDL cholesterol, representing the first major advance in the area since widely used statin drugs hit the market in the late 1980s. (Dennis and Bernstein, 6/8)
The Associated Press:
FDA Weighs Target Population For Amgen Cholesterol Drug
Federal health regulators said Monday a highly-anticipated experimental drug from Amgen significantly lowers bad cholesterol. But officials have questions about who should take the drug and whether to approve it based on currently available data. The Food and Drug Administration posted its review of Amgen's Repatha ahead of a public meeting to consider its approval. Repatha is the part of a new class of injectable, cholesterol-lowing drugs that work differently than older statin drugs. The new drugs are considered the first major advance in lowering bad, or LDL, cholesterol in more than 20 years, and analysts expect them to generate billions in sales. (Perrone, 6/8)
Amgen's Respatha Effective; Question Is For Which Patients: FDA
Amgen Inc's experimental drug Repatha lowered cholesterol in clinical trials and did not cause a marked disparity in deaths or serious adverse events but showed potential safety issues that should be explored, according to a preliminary review by the U.S. Food and Drug Administration. The review was published on Monday on the FDA's website before a meeting on Wednesday of outside advisers to the agency who will discuss the drug and recommend whether it should be approved. (Clarke, 6/8)
Meanwhile, a large heart study appears to boost Merck's diabetes drug Januvia and a Gaithersburg-based biotech firm helps target antibiotic-resistant microbes -
No Heart Safety Issues Seek With Merck Januvia Diabetes Drug: Study
Details of a large heart safety study presented on Monday appear to give Merck and Co's diabetes drug Januvia a clean bill of health, possibly setting the stage for a return to sales growth for the drugmaker's biggest product. Merck in April said the study, called Tecos, of 14,724 patients with type 2 diabetes and a history of heart disease demonstrated that adding Januvia to usual care did not increase major heart problems any more than adding a placebo, removing a cloud that has been holding back sales of the medicine and the company's share price. (Berkrot, 6/8)
How OpGen Is Using Genetic Testing To Battle Superbugs
When antibiotics were created nearly 75 years ago, they were deemed a miracle drug. But over time, some microbes have built up a resistance. The current nemesis of antibiotics are known as multi-drug resistant organisms or MDROs. Or, superbugs. They can be especially threatening at hospitals, where patients who are infected could transmit the superbugs to others. (Babcock, 6/8)