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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.
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.
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.
The FDA’s Gastrointestinal Drugs Advisory Committee voted unanimously (17-0) to recommend accelerated approval of Intercept Pharmaceuticals’ obeticholic acid (OCA) in combination with ursodeoxycholic acid (UDCA) for adults with primary biliary cirrhosis (PBC) who don’t respond well enough or who cannot tolerate UDCA.
An FDA Advisory Committee rejected accelerated approval for Clovis’ rociletinib for hard-to-treat lung cancer patients with a specific mutation, T790M. The panel did not find the data convincing, the drug did not look better than what is already available, and the correct dose was not clear.
Centers for Disease Control and Prevention (CDC) officials held a telebriefing for reporters on the Zika virus, just a week after senior administration officials did the same thing. The call was held to discuss the publication today in the New England Journal of Medicine of a CDC paper announcing it is now confirmed that the Zika virus causes microcephaly and other brain-related birth defects.