There was no Weekly Roundup last week due to a confluence of circumstances, including the fact that it seemed a very quiet week last week when it comes to many of the things I watch. But this week, there was quite a bit of activity and a lot of it was good stuff – and so here it is:
- FDA Approves Anticoagulant Reversal Agent – The agency announced that accelerated approval was granted to Praxbind (idarucizumab) for use in patients who are taking anticoagulant Pradaxa (dabigatan) during emergency situations where there is a need to reverse the blood-thinning effects of the treatment. FDA noted that while the treatment with Pradaxa is life-saving for some patients, reversal is sometimes medically necessary. Need a refresher on the difference between Accelerated Approval, Fast Track, Breakthrough Therapy and Priority Review? FDA provides it here.
- Approval of Pancreatic Cancer Treatment – A new approval in an area with limited current options – FDA announced approval Onivyde (irinotecan lipsome injection) in combination with fluorouracil and leucovorin to treat patients with advanced pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy. The agency stated that in clinical trials, the patients receiving Onivude plus fluorouracil/leucovorin had a delay in average amount of time to tumor growth of 3.1 months compared to 1.5 months for those receiving flueoouracil/leucovorin. The National Cancer Institute estimates that there will be nearly 50,000 pancreatic cancer cases diagnosed in the U.S. in 2015. Onivyde had Priority Review and orphan drug designations. You can check out the multimedia press release from the company Merrimack here.
- New Treatment Approved for Potassium Buildup – Hyperkalemia – a condition in which the amount of potassium in the blood is high leading to dangerous and even fatal changes in heart rhythm, has a new treatment available with the FDA approval of Veltassa (patiromer for oral suspension). The buildup of potassium can occur when the kidneys are not able to remove enough potassium from the body. The new medication works by binding potassium in the gastrointestinal tract thereby decreasing its absorption. It will carry a boxed warning because it also can bind to other orally administered drugs and will also have a Medication Guide. The company’s press release can be found here.
- FDA Seeks Consumer Reps for AdComms – Last week Eye on FDA carried a posting about the vacancy rates on AdComms (and the inconsistent way FDA tracks and reports them) and this week the agency is seeking to fill them – at least some of them. The FDA blog FDAVoice carried an appeal for those who might be interested. Having set through scores of AdComms in my time, I can assure you that the voice of the consumer representative is an important one bringing some real world perspective to the proceedings that is often needed. Reps are often from consumer/patient organizations, but they don’t have to be. The posting on the FDA blog carries a list of the current vacancies as well as links to the application process.
Photo courtesy of Anne Becker