Eli Lilly has won a nod from NICE for its anticipated blockbuster and Humira competitor, Olumiant, a modicum of good news for a drug the FDA rejected in April.
England’s cost watchdog, in final guidance, determined the drug was cost effective and recommended its routine use by the National Health Service for adults with rheumatoid arthritis whose disease hasn’t responded well to conventional disease-modifying antirheumatic drugs (DMARDs).
Reviewers said it is was found to be more effective than most DMARDs and as effective as Humira, the world’s best-selling drug. Lilly has offered the NHS an undisclosed discount to the NHS for the med, which has an average estimated list price in England of £10,501 ($13,000) per patient per year.
The recommendation followed its approval in February by the European Medicines Agency.
But Lilly and partner Incyte have not been as fortunate with the FDA. In April, they received a complete response letter asking for additional clinical data to get a fix on appropriate doses and more data about risks, adding significant delays and costs for the two. Lilly did not change its financial guidance as a result of the delay.
A presage of the FDA's concerns was the fact the agency added 3 months to its review time to conduct “additional data analyses.”
When they got the bad news, Lilly and Incyte said they “disagree with the agency’s conclusions,” adding that the timing of a resubmission “will be based on further discussions with the FDA.”
Analysts had forecast the drug could hit annual sales of $1.8 billion by 2022. With the delays, Lilly finds itself far behind Pfizer’s already approved Xeljanz, as well as Kevzara a drug from Regeneron and Sanofi which was approved in May and which is slotted to reach about $5 billion in sales by 2022.