Eli Lilly and Co.’s hopes for rolling out a potential blockbuster drug for rheumatoid arthritis received a major setback Friday, as federal regulators approved only a low-dose version of the medicine and slapped a “black box” warning on the label, pointing out serious risks of infections, malignancies and blood clotting.
The long-anticipated drug, Olumiant, was approved to treat adults with moderately-to-severely active rheumatoid arthritis who have had inadequate responses to other widely used treatments known as TNF inhibitors.
The Food and Drug Administration approved a 2-miligram dose of the once-daily oral medication. Lilly had sought approval for a higher, 4-miligram dose. An FDA advisory panel had recommended against the higher dosage, citing safety concerns.
The Indianapolis-based drugmaker has been waiting for months for approval for the drug, also known by its generic name, baricitinib. The drug was developed by Delaware-based Incyte Corp. Lilly paid Incyte $90 million for global rights to the drug and led it through clinical trials.
Last year, the FDA rejected the drug, saying it needed substantially more information about baricitinib’s safety and recommended doses.
Last July, Lilly said it might have to conduct another clinical trial, a move that could take 18 months and costs additional millions of dollars. A month later, however, the FDA said Lilly would not have to conduct another expensive trial after all.
Before Friday’s news, some analysts had high hopes for the drug. Goldman Sachs analyst Jami Rubin had predicted the drug could ring up $2.2 billion in annual sales by 2025. But some analysts warned sales could be limited if the FDA rejected the high dose.
“Bears may argue that without the 4-mg dose, the perception and commercial profile of baricitinib is wounded,” Dr. Tim Anderson, a drug analyst at Bernstein, wrote in a research note.
Nevertheless, Lilly sounded an upbeat tone in announcing the FDA decision.
“We are pleased to provide RA patients in the U.S. an effective treatment option with Olumiant, as people with RA who have had an inadequate response to TNF inhibitors are generally considered to be some of the most difficult-to-treat RA patients,” said Christi Shaw, president of Lilly Bio-Medicines.
Rheumatoid arthritis is a chronic and progressive form of arthritis.
Lilly said it will launch Olumiant by the end of the this quarter.
Shares in Lilly were down 0.4 percent Friday afternoon, to $84.71 each, on an otherwise strong day for the market.