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FDA Advisory Committee Recommends Approval Of Novo Nordisk's Insulin/Glp-1 Combination

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.

American Society of Cataract and Refractive Surgery (ASCRS)

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.

American Pain Society (APS)

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.

International Workshop on NASH Biomarkers

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.

Heart Rhythm Society (HRS)

Cardiac rhythm devices are getting less, not more differentiated, and that is making cost and insurance coverage more important. Rotor mapping technology has been controversial from Day 1, and the OASIS data suggest it may no longer have any role. Though Abbott’s Topera still has defenders, it may be tough to find new customers. Electrophysiologists are excited about subcutaneous ICDs and leadless pacemakers for the right patients, and use is expected to increase. MRI compatability is not a big concern with electrophysiologists, and they are not choosing devices for that reason. Quadripolar leads are almost routine today, and St. Jude Medical may have a better mousetrap (quadripolar lead) but doctors want to see more data on MultiPoint Pacing.

American Academy of Neurology (AAN)

There was positive news for: ♦ AbbVie and Biogen’s daclizumab and Roche/Genentech’s ocrelizumab in RRMS (but Biogen’s Tysabri failed to improve disability in SPMS). ♦ Alnylam’s patisiran in amyloidosis. ♦ bluebird bio’s Lenti-D in a very small trial in CALD. ♦ Ionis and Biogen’s nusinersen in SMA. ♦ Lundbeck and Otsuka’s idalopirdine in cognition in Alzheimer’s.  Medtronic’s Reveal Linq in detecting AFib.  Mitsubishi’s edaravone and MediciNova’s ibudilast in ALS. ♦ Neurocrine’s valbenazine in tardive dyskinesia.  Sage Therapeutics’ SAGE-547 in a rare epilepsy, SRSE. ♦ Taro’s dichlorphenamide in periodic paralysis, though toxicity is an issue. Alnylam’s patisiran in amyloidosis. ♦ bluebird bio’s Lenti-D in a very small trial in CALD. ♦ Ionis and Biogen’s nusinersen in SMA. ♦ Lundbeck and Otsuka’s idalopirdine in cognition in Alzheimer’s. ♦ Medtronic’s Reveal Linq in detecting AFib. ♦ Mitsubishi’s edaravone and MediciNova’s ibudilast in ALS. ♦ Neurocrine’s valbenazine in tardive dyskinesia. ♦ Sage Therapeutics’ SAGE-547 in a rare epilepsy, SRSE. ♦ Taro’s dichlorphenamide in periodic paralysis, though toxicity is an issue.

American College of Cardiology

Some years, drugs dominate the American College of Cardiology (ACC) meeting, and other years, devices take center stage. This year, drugs and devices shared the stage pretty equally. More than 18,000 people attended the meeting, with 299 exhibitors and 2,400 posters and oral presentations. There was a change in format for 2016, with more participatory sessions and deep dives into key topics.