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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee was split (12-11) on whether Boehringer Ingelheim and Lilly’s Jardiance (empagliflozin), an SGLT2 inhibitor, should get a label that it reduces the risk of cardiovascular death, but the devil (or the angel) may be in the details.
The Obama administration is taking a number of new steps, outlined in this report, to combat the opioid and heroin epidemic.
Interventional cardiologists are anxious for FDA approval of TAVR in intermediate-risk patients, but there is no waiting list of patients. The durability of TAVR is a concern, but it is not much worse than surgical valves. Patients may need to be followed for ≥10 years with TAVR, but a valve-in-valve procedure is an option if there is a failure. And the durability issue will not delay FDA approval of new valves Leaflet thickening also is a problem, but again, not a technology killer, just more monitoring and perhaps warfarin for life in some patients. Endocarditis has probably been an under-appreciated complication. To get the cost down, some centers are taking a minimalist approach. As more valves become available, mMost U.S. centers expect to use 2-3 of them only, most likely Sapien, CoreValve, and Lotus (now that the pacemaker rate is starting to come down). The outlook for other valves is murkier, unless they win on price.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 12-2 to recommend approval of Sanofi’s iGlarLixi, a fixed-dose, single-injection combination of Lantus (insulin glargine) + Lyxumia (lixisenatide), a GLP-1 agonist, to treat adults with Type 2 diabetes as an adjunct to diet and exercise.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted unanimously to recommend approval of Novo Nordisk’s Xultophy (IDegLira), a combination of Tresiba (insulin degludec) + Victoza (liraglutide), a GLP-1 agonist, to treat adults with Type 2 diabetes as an adjunct to diet and exercise. This would be the first combination of a GLP-1 agonist and a basal insulin in one injection.
A quick visit to this meeting offered only time to look at a couple of topics: dry eye and glaucoma. Shire’s lifitegrast showed, once again, that it can improve the symp-toms of dry eye, this time in the OPUS-3 trial. Signs were measured but not reported. Will that be good enough for the FDA? Neurostimulation and drug-eluting punctal plugs and rings are also in development to treat dry eye. In glaucoma, MIGS is gaining popu-larity as a way to reduce if not eliminate the medication burden. Use of Glaukos’ iStent is likely to increase, though several competitors are on the horizon. Allergan’s bimatoprost SR punctal plugs are an appealing alternative to glaucoma eyedrops, but there was more interest in ForSight Vision5’s bimatoprost-eluting ring.
While primary care doctors are prescribing fewer opioids, pain doctors are still willing to prescribe them, despite pressure from the FDA, CDC, and insurers. Trevena’s oliceridine, which looks promising in acute postoperative pain, with a reduction in hypoventilation, but the constipation rate needs to be watched in Phase III. Endo’s Belbuca (buccal buprenor-phine) is launching slowly, but pain doctors expect it to pick up. Pacira Pharmaceuticals’ Exparel got generally positive comments – except for cost. There are a few promising drugs in development, but not as many as 10 years ago. And the FDA is pushing for novel agents, not me-toos.
While there is a lot of work going on to find a biomarker for use in NAFLD and NASH, the efforts are fragmented, competitive instead of collaborative, and early. The lack of any regulatory input at this conference didn’t help. It is clear the field still has a long way to go to identify patients and stage them, much less monitor response to drug therapy. And with outcomes trials likely to be necessary, it may be years before a biomarker is ready for prime time.