FDA delays decision on Lilly RA hopeful
US regulators are to delay a decision on Eli Lilly’s potential rheumatoid arthritis blockbuster, baricitinib, by three months in order to consider further information submitted by the manufacturer.
Lilly has high hopes for the drug, which will likely be approved in the EU in the coming months after backing from regulators.
New CEO David Ricks hopes that baricitinib, which will likely be marketed in the EU as Olumiant, will lift sales and spirits in the company after a disastrous end to 2016, which saw Alzheimer’s drug solanezumab fail in a late-stage trial.
The company is looking for new revenues as patents expire on its Cialis (tadalafil) erectile dysfunction drug, although last week a US court said Lilly may block Teva and others from selling generics of its Alimta (pemetrexed) cancer drug.
Trial data shows that baricitinib, developed in partnership with Incyte, could be more effective than Humira. Lilly’s drug is administered in a pill, which patients will likely find more convenient than injections of Humira.
The FDA was set to make a decision on baricitinib this week – but has postponed this decision by three months.
Lilly said the FDA extended its action data to review additional data analyses submitted by Lilly in response to requests for information from the regulator.
The FDA said it determined the additional information to be a major amendment to the filing, causing a three-month delay to the review. Lilly first filed baricitinib with the FDA in January last year.
Anthony Ware, senior vice president, product development and interim president of Lilly Bio-Medicines, said: “We will continue to work closely with the FDA throughout the review process and we believe that baricitinib has the potential to be an effective treatment choice, especially for those patients for whom current therapies are not adequately addressing their disease.”
Lilly said the delay does not affect its previously-issued financial guidance for 2017.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.