Eli Lilly and Co. is not giving up without a fight on baricitinib, an anti-inflammatory medicine that has had a few big setbacks from federal regulators in the past two years.
The Indianapolis-based drugmaker is pushing to get the drug approved for a second use: treatment of adults with moderate to severe atopic dermatitis, a serious form of eczema characterized by intense itching, dry skin and inflammation.
Lilly said Monday that the drug met its primary endpoint in two late-stage clinical trials in patients with the skin condition. More than 6 million adults in the U.S. have moderate to severe atopic dermatitis, according to the Asthma and Allergy Foundation of America.
That’s usually the last major hurdle for a drugmaker as it prepares to seek approval from the U.S. Food and Drug Administration to market the drug to physicians.
But as Lilly knows, there are no guarantees for what regulators might do. That’s especially true for baricitinib, which has had a long and twisting journey on its way from the clinic to the marketplace.
The much-anticipated drug, originally developed for rheumatoid arthritis, was viewed as a potential blockbuster, in part because most other new rheumatoid arthritis drugs are injected, making them less appealing for patients. Baricitinib, also known by its commercial name, Olumiant, is a tablet taken orally.
Analysts were bullish. Goldman Sachs drug analyst Jami Rubin predicted the drug could ring up $2.2 billion in sales by 2025.
But in a surprise move, the FDA rejected the drug in April 2017, saying it needed substantially more information about the drug’s safety and best doses. In July 2017, regulators said Lilly might need to conduct another expensive, time-consuming trial.
Then, in an about-face just a few weeks later, the FDA said Lilly would not have to conduct another trial after all, and just asked Lilly to resubmit the drug with additional safety and efficacy data.
However, in June 2018, when the FDA finally did approve the drug, it did so with severe restrictions, citing safety risks of infections, malignancies and blood clotting. Lilly could only sell a low-dose version of the drug, reducing the number of patients eligible for the treatment. And the drug was slapped with a “black box” warning, the strictest warning put on the labeling of prescription drugs.
Sales of baricitinib last year through Sept. 30 were $132.5 million. Lilly will report full-year results on Feb. 6.
Lilly’s latest announcement sounded an optimistic note for the drug. In announcing the results of its two clinical trials for the drug in treating severe atopic dermatitis, the company said, “a statistically significant proportion of patients” treated with baricitinib achieved a score of “clear” or “almost clear,” compared to patients treated with a placebo.
The company said it plans to share the full data results in peer-reviewed journals and scientific conferences. It is also studying the drug in other ongoing trials. Lilly is also developing baricitinib for lupus and hair loss.
“We are encouraged that baricitinib met the primary endpoint in these two studies, and look forward to seeing the collective results of all five studies,” said Dr. Lotus Mallbris, vice president of immunology development at Lilly.
Shares of Lilly dipped about 1 percent in midday trading Monday. But some analysts said they were pleased with the news.
“This represents a first-in-class opportunity for Lilly and underscores our belief that its pipeline is underappreciated,” wrote Louise Chen, an analyst at Cantor Fitzgerald in New York, in a note Monday to clients.