FDA Gives The OK To Biosimilar Version Of Humira
The Food and Drug Administration's approval of Duchenne Muscular Dystrophy drug also continues to attract news headlines.
The Wall Street Journal:
FDA Approves Amgen’s Biosimilar Version Of Humira
U.S. regulators approved Amgen Inc.’s copy of the AbbVie Inc.’s anti-inflammatory treatment, Humira, which was the second-biggest selling drug in 2015. Amgen’s drug, known as Amjevita, is only the fourth so-called biosimilar—which are copies of complex biotech medicines—approved by the U.S. Food and Drug Administration. Biosimilars were authorized as part of the federal health-care overhaul to reduce spending on such biotech drugs, much like generics have cut the costs of pills. (Minaya, 9/23)
Duchenne Muscular Dystrophy Drug: Did FDA Make The Right Call?
When 15-year-old Billy Ellsworth stepped up to the microphone at a Food and Drug Administration public meeting in April, he had no way to know he was part of a historic shift in how the government considers the desires of patients and their advocates in evaluating new drugs. Ellsworth has Duchenne muscular dystrophy, a muscle-wasting disease, that mainly affects boys. And he was taking an experimental drug that the FDA was trying to decide whether to approve. (Harris, 9/24)
In other news related to drugs and drug development —
Could A Cheap, Simple Medication Head Off A Heart Attack?
When Harry Selker was working as a cardiologist in the 1970s, clot-busting drugs were showing great promise against heart attacks. But their life-saving properties were very time sensitive. "If you give it within the first hour it has a 47 percent reduction of mortality; if you wait another hour, it has a 28 percent reduction; another hour, 23 percent. And people were taking about 90 minutes to make that decision," he recalls. "So they were losing the opportunity to save patients' lives." (Rath, 9/23)
Ohio State Researcher Testing Drugs To Treat Lewy Body Dementia
An Ohio State University researcher is enrolling patients in the first U.S. clinical trials of two drugs being tested in the treatment of Lewy body dementia, one of the most common but least talked about neurodegenerative diseases. "This disease is often misdiagnosed and undertreated and exacts a high toll on those who have it," said Dr. Brendan Kelley, a Wexner Medical Center neurologist who is leading the studies. Though not nearly as well-known as Alzheimer’s, which accounts for more than half of dementia diagnoses in the United States, Lewy body is the second-most frequent type of progressive dementia. Nearly 1.4 million Americans have the disease, but the number likely is higher because its symptoms often closely resemble other more-recognized disorders, Kelley said. (Pyle, 9/25)