After years of backlash, Lilly is slashing the price of insulin

Eli Lilly will make dramatic cuts to the prices of some of its older insulin products, the company said today, an effort to lower patients' out-of-pocket costs amid public uproar over the price of diabetes care.

As STAT's Matthew Herper and Ed Silverman report, Lilly is immediately lowering the price of Insulin Lispro, a generic version of the insulin Humalog, from $82 a vial to $25 a vial, which was its price in 1999. The company will also cut the list price of Humalog, its most commonly prescribed insulin, by 70% in the fourth quarter of this year, using the intervening months to negotiate with pharmacy benefit managers and health insurance plans.

Experts and advocates welcomed the moves, but worried about how far-reaching they would truly be. Stacey Dusetzina, a professor at Vanderbilt University School of Medicine, worried that Lilly might be taking advantage of the huge spread between list prices and the prices insurers pay after Lilly pays them rebates.

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Biotech

The next CRISPR fight is on the horizon

MARIA FABRIZIO FOR STAT

While the litigation over the discovery of CRISPR genome editing has dominated headlines, the latest evolution of the revolutionary technology could bring a messy legal squabble of its own.

As STAT's Jason Mast, Allison DeAngelis, and Megan Molteni report, a precise new form of CRISPR called prime editing is already the subject of dueling claims from rival companies. But whereas the first was waged by two academic rivals claiming the original invention, the new battle is shaping up to be a free-for-all among a multitude of companies and labs.

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Rare disease

A landmark approval for a debilitating condition

The FDA approved a drug for Friedreich's ataxia yesterday, marking the first medicine for a rare neurological disease that leads to progressive damage to the nervous system.

The treatment, from Reata Pharmaceuticals, led to statistically significant improvements in neurologic function compared to a placebo in a single clinical trial. But in FDA documents posted ahead of the agency's decision, staff described the data as "not exceptionally persuasive," casting doubt on whether Reata's treatment would win approval.

In a research note previewing the FDA's decision, SVB Securities analyst Joseph Schwartz estimated peak sales of Skyclarys could reach $625 million, based on reaching approximately 30% of the U.S. patients diagnosed with FA.

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Regulatory

The FDA's new boss in neuroscience

The surprise departure of long-time FDA official Billy Dunn has left the drug industry guessing at the regulatory philosophy of his lesser-known successor, Teresa Buracchio.

As STAT's Adam Feuerstein and John Wilkerson report, Dunn's reputation as a flexible regulator makes Buracchio's assent to the role of acting director of the Office of Neuroscience a potential pivot for the FDA. Buracchio appears to have largely worked in Dunn's shadow in recent years. Many patient groups and companies that make neurology drugs — and the lobbyists who represent them — said they knew little about her.

It won't take long to see the impact, if any, on a changing of the guard. In March, the FDA will decide on the approval of a new treatment for the neurological disease called Rett syndrome developed by Acadia Pharmaceuticals. Buracchio will also oversee a meeting of outside experts who will review clinical data on tofersen, a treatment for an inherited type of ALS made by Biogen. And Buracchio is overseeing the potential final approval for the Alzheimer's disease drug Leqembi, the details of which will be closely watched by physicians, patients, and industry.

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