FDA Advisory Panel Recommends Expanded Fish Oil Drug Use Which Could Translate Into Billions In Sales For Maker
Vascepa, which right now is only approved for a relatively narrow group of patients with extremely high levels of triglycerides, costs around $300 a month. The advisory panel unanimously supported the expansion based on recent study results showing the drug can cut rates of life-threatening heart problems in high-risk patients. Other news on the pharmaceuticals and the FDA focuses on a warning against over-the-counter medicine sold at the Dollar Tree, a Chinese cancer drug, and more.
The Associated Press:
US Panel Backs Wider Use Of Fish Oil To Prevent Heart Attack
Government health experts on Thursday recommended broader use of a prescription-strength fish oil drug to help many more patients at risk for heart attack, stroke and related health problems. Currently the drug, Vascepa, is approved for a relatively narrow group of patients with extremely high levels of triglycerides, a type of fat in the blood linked to heart disease. (Perrone, 11/14)
The Washington Post:
FDA Panel Endorses Wider Use Of Fish-Oil Drug To Protect Against Heart Problems
The 16-0 endorsement of the FDA advisory committee puts Dublin-based Amarin Corp. one step closer to widespread distribution of Vascepa, a drug the company has said could be worth billions of dollars annually. The FDA, which usually follows such guidance, could make a long-awaited final decision next month. “There’s a definite need for additional therapeutic approaches,” said Kenneth D. Burman, chief of the endocrine section at MedStar Washington Hospital Center, who chaired the panel. Despite some side effects, he said, “this seems a very useful new agent for addition to the armamentarium for the treatment of these patients.” (Bernstein, 11/14)
The Wall Street Journal:
FDA Panel Backs Expanding Use Of Fish-Oil Derived Drug
Sales of Vascepa could surpass $3 billion if the FDA approves a wider label, according to analysts. Last year’s sales of the drug totaled nearly $230 million. Vascepa was approved in 2012 to treat adults with severe hypertriglyceridemia, or very high levels of triglycerides, which are fats that circulate in the blood. High triglyceride levels can signal the presence of metabolic abnormalities that can damage the heart and blood vessels. About four million Americans have severe hypertriglyceridemia, according to Amarin, and 70 million have elevated triglyceride levels. (Hopkins and McKay, 11/14)
Bloomberg:
FDA Approves First Chinese Cancer Drug For U.S. Patient Use
The U.S. Food and Drug Administration has granted approval to a blood cancer drug from Beijing-based BeiGene Ltd., paving the way for American patients to access a Chinese cancer therapy for the first time. The accelerated approval -- ahead of even China’s own national drug regulator -- marks a breakthrough for the growing legion of Chinese biotech companies determined to take on the world’s biggest pharmaceutical companies in medical innovation and scientific research. (11/14)
Stat:
A Drug Maker Courted Controversy When It Shut Out A Family-Run Rival. Now Some Patients Say The Medicine Isn’t Working
In late 2018, Catalyst Pharmaceuticals (CPRX) was granted exclusive marketing rights to sell its new drug, called Firdapse, after the Food and Drug Administration approved the medicine. The move precludes any competition for seven years. ...Over the past few months, about 30 people who suffer from Lambert-Eaton myasthenic syndrome, or LEMS, have switched back to the older treatment, known as Ruzurgi. For more than two decades, a small, family-run company called Jacobus Pharmaceuticals made its drug available on a compassionate use basis to a few hundred people while pursuing formal FDA approval. (Silverman, 11/15)
Reuters:
Generic Drug Group Sues Over California Law Combating 'Pay-For-Delay' Deals
A trade group for generic drugmakers has filed a lawsuit challenging California’s recently-enacted law that bars manufacturers of brand name drugs from paying other companies to delay releasing generic drugs to resolve patent litigation. The Association for Accessible Medicines (AAM) in a lawsuit filed in federal court in Sacramento, California, on Tuesday argued that the nation’s first-of-its-kind law to combat so-called “pay-for-delay” settlements is unconstitutional. (Raymond, 11/14)
New Hampshire Union Leader:
NH Joins Multi-State Lawsuit Against Drug Companies
The attorney general’s office announced Wednesday that New Hampshire has joined a multi-state lawsuit against 20 drug companies, alleging that they conspired to fix prices on generic prescription drugs. The amended complaint alleges that Teva Pharmaceuticals and 19 of its competitors were involved in a broad conspiracy to artificially inflate and manipulate prices, reduce competition and unreasonably restrain trade for more than 100 different generic drugs. The drugs at issue account for billions of dollars of sales in the United States. (11/13)
