Device made by a J&J acquisition might actually work

My colleagues Lizzy Lawrence and Matt Herper report: Independent researchers set out on a trial thinking that they might disprove a device made by Shockwave Medical, the company that Johnson & Johnson is now buying for $13 billion. The study, out today, ended up showing the device might actually work.

The device, called a coronary sinus reducer, is meant to reduce chest pain by forcing blood backward through the heart's veins. The primary goal of the small trial was to use magnetic resonance imaging to see if this happened. Half of the 61 patients - 51 of them male and seven female - were given the device and half were given a placebo procedure. There was no difference in the MRI measure.

But the daily number of angina episodes was reduced by 40%, meaning the device appears to have the intended effect, despite not working as researchers expected.

Read more about the device, which is available in Europe and the U.K. but was previously rejected by the FDA, here. And read about J&J's good news from earlier in the conference, about another device that had doubters, here.

PREVENTION

Could an app make statins more widely available?

Matt reports: Statins, the class of cholesterol-lowering medicines that include atorvastatin (Lipitor) and simvastatin (Zocor), are among the most prescribed drugs in the U.S. and are a key part of cardiology's armamentarium. These drugs consistently reduce heart attack and stroke rates with relatively few side effects. But even though they are generic, experts say far too few people are taking a statin every day.

Attempts to make the medicines available over the counter have consistently run aground at the Food and Drug Administration. AstraZeneca is trying a new approach with the lowest dose of its statin, rosuvastatin (Crestor) — it's developed a web app. In results presented today, 90% of 1,196 participants who used the app were able to come to the same conclusion as a physician about whether they should take a statin. And then 98% of consumers were able to correctly use the drug.

"Ideally, I would love everybody to talk to their physician and get guidance, but honestly, that way hasn't worked all that well in the United States," said Martha Gulati, director of preventive cardiology at the Smidt Heart Institute at Cedars-Sinai. "Because it's the 5 mg dose, the low intensity dose, less side effects [than higher doses], I feel very good" about this kind of program being rolled out.

The next step is for AstraZeneca to take the data to the FDA. Stay tuned.

Interventional

Another success for interventional cardiology's TAVI

Matt reports: If you want an image of how much treatments for heart disease have changed, watch Mick Jagger dance. In 2019, he underwent a transcatheter aortic valve implantation (TAVI). This technology has changed how heart valve disorders are treated. (Read the backstory here.)

TAVI got another big win, one that is not funded by either of the manufacturers who developed it (that would be Edwards Life Sciences and Medtronic). In a trial of low-risk surgical patients funded by the German Heart Foundation, the incidence of death was 2.6% for TAVI patients but 6.2% for those who got a surgical repair. The study is published in the New England Journal of Medicine.

In an accompanying editorial, Pinak Shah of the Brigham & Women's Hospital writes that there still needs to be more follow-up on the long-term risks and benefits of TAVI. "However," he wrote, "with each passing year, the unknowns are becoming knowns, and the future of TAVI appears to be bright."

biotech

Ionis' rare disease win sets stage for bigger target

After reporting positive Phase 3 results yesterday, Ionis is seeking FDA approval of its treatment olezarsen in a rare disease called familial chylomicronemia syndrome (FCS), a genetic condition that leads triglyceride levels to skyrocket.

It's a big step for the company and for patients. If approved, olezarsen would be Ionis' first solo drug launch and it would be the first FCS drug approved in the U.S. But what investors are closely watching out for is how the drug fares in ongoing Phase 3 trials in severe hypertriglyceridemia, a much more common condition.

"While getting FCS approval is a nice win, what matters for the stock and the drug's overall revenue poptential [sic] is olezarsen's competitiveness in the much larger severe hypertriglyceridemia market," analysts at Stifel wrote.

There are some signs the drug would likely be effective in the severe hypertriglyceridemia studies. In a Phase 2 trial in patients with moderate to severe hypertriglyceridemia that was also reported yesterday, the subgroup of patients with severe hypertriglyceridemia saw an over 80% reduction in triglycerides over six months.

While Ionis is still open to partnering with companies in the future, its priority is to focus on bringing drugs to market on its own, CEO Brett Monia said in an interview. "Nobody knows our babies better than we do."

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