- The coronavirus outbreak has forced the Food and Drug Administration to delay by two months a highly anticipated advisory meeting for obeticholic acid, which could become the first-ever drug for the fatty liver disease nonalcoholic steatohepatitis.
- Importantly for the drug's developer, Intercept Pharmaceuticals, obeticholic acid's timeline for potentially securing an FDA approval is still intact. The agency will decide whether to clear the drug by Jun. 26.
- While NASH's prevalence in the U.S. is growing fast, obeticholic acid has its drawbacks, and it's unclear if Intercept will be able to meet the multibillion-dollar financial forecasts for the drug. The pandemic, meanwhile, adds another wrinkle to any drug launch.
Intercept's announcement of the advisory panel delay isn't a surprise given the widening ripple effects of the coronavirus pandemic. A number of medical conferences, for instance, have either been canceled, postponed or moved online.
Even a virtual advisory panel would be a tall order, given the meetings bring together outside experts, patient advocates, company executives and FDA scientists to weigh the merits of an experimental drug. The FDA is "working on the infrastructure to handle virtual panels," wrote Cantor Fitzgerald analyst Alethia Young.
Intercept's disclosure could be taken positively, because obeticholic acid's path to market may not change. The advisory panel meeting will take place on Jun. 9, not Apr. 22, which is roughly three weeks before the agency's current Jun. 26 approval deadline on the drug. That's "the silver lining here," said Young. And indeed, shares climbed 15%, to about $71 apiece, in early Thursday trading.
Still, Young noted the timeline from advisory panel to drug approval decision is typically six weeks. A delay wouldn't be a shock, given the current state of the outbreak in the U.S. — some 69,000 confirmed cases according to Johns Hopkins data as of Mar. 26 — and its impact on various aspects of the economy.
That would add more questions to an already uncertain drug launch, should obeticholic acid be cleared through to market. There are no approved drugs for NASH, a disease that's become more common alongside rising rates of obesity in America. NASH occurs when the livers of some patients with fatty liver disease become inflamed and scarred, which can lead to liver failure.
NASH is estimated to affect some 15 million U.S. adults. It's typically treated with lifestyle interventions, like changes to diet and exercise, or other measures to control patients' metabolic and heart health.
Intercept's drug is meant to help reduce patients' liver damage, but it isn't a panacea. Obeticholic acid's most significant positive effects — a reduction in liver scarring — were observed in about a quarter of patients on its highest tested dose. The drug causes itching and a rise in cholesterol, which is potentially worrisome given patients with NASH often are at high risk of heart problems.
The long-term health benefits to the drug are also up for debate. Intercept is tracking whether obeticholic acid can lower rates of death, hospitalization, and cancer, but has yet to report data. The "impact of obeticholic acid on quality of life and other patient-reported outcome measures remains unclear," wrote the nonprofit drug pricing watchdog ICER, in a report earlier this month.
ICER, which is increasingly influential with insurers, concluded that obeticholic acid is best suited for NASH patients with significant liver scarring and no history of heart disease. CEO Mark Pruzanski told BioPharma Dive earlier this year that those kinds of patients are where Intercept is focusing its efforts — on the roughly 500,000 who the company believes have advanced fibrosis and are being treated by specialists.