Drug company Eli Lilly says their much-awaited pill for rheumatoid arthritis has been rejected by the Food and Drug Administration. It’s the company’s second drug development setback since November.
A letter to the company from the FDA said that they needed more information about baricitinib’s safety and the best doses, Lilly said Friday in a statement.
The drugmaker disagrees with FDA’s conclusions but will work with the agency on a plan to eventually get baracitinib approved for U.S. patients.
The arthritis drug, which has the proposed brand name Olumiant and was approved for use in Europe in February, was expected to be a big seller in part because most other new rheumatoid arthritis drugs are injected, making them less appealing for patients.
“We are disappointed with this action,” said Christi Shaw, president of the Lilly division that developed the drug, in the company’s statement, adding that the company remains confident in the drug’s ability to safely treat moderate and severe rheumatoid arthritis.
About 23 million people worldwide -- three-fourths of them women -- have rheumatoid arthritis, an autoimmune disorder that happens when the immune system mistakenly attacks a person’s own body tissues. The chronic disorder causes painful swelling and progressive destruction of joints, which can leave them deformed and, in severe cases, lead to disability. It can also damage other body parts, including the skin, eyes, lungs, heart and blood vessels.
Rheumatoid arthritis can strike at any age, but typically begins between the ages of 40 and 60, and if someone in your family has had it, your odds for the condition may be higher.
Eli Lilly & Co. and Incyte Corp., its partner in developing baracitinib, applied for FDA approval of the drug in January 2016. Normally the review process takes 10 months, but this January, FDA said it needed three additional months to review more information. Still, drug industry analysts as recently as this week were advising clients that approval of baracitinib was likely.
Despite the setback, Lilly reaffirmed its 2017 financial forecasts Friday, for earnings per share of $2.69 to $2.79, excluding one-time items, and revenue between $21.8 billion and $22.3 billion. It said Incyte, which is based in Wilimington, Delaware, was evaluating the rejection’s impact on its position and would update investors when it reports first-quarter results, likely in mid-May. Lilly is expected to report its quarterly results on April 25.