The US Food and Drug Administration (FDA) has extended the review period for Eli Lilly and Incyte’s supplemental New Drug Application (sNDA) for OLUMIANT (baricitinib).
The new drug is used for the treatment of adults with moderate to severe atopic dermatitis (AD).
The FDA extended the Prescription Drug User Fee Act (PDUFA) action date to early Q3 2021 to review the additional data submitted by Lilly in response to FDA’s recent information requests.
Lilly Bio-Medicines senior vice-president and president Ilya Yuffa said: “We look forward to continuing to work closely with the FDA to bring baricitinib to patients living with moderate to severe atopic dermatitis.
“We remain confident in baricitinib and believe it has the potential to be an effective new treatment option for these patients.”
baricitinib is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly. It was approved in the US and over 70 countries for the treatment of adults with moderate to severe rheumatoid arthritis (RA).
Recently[PSP1] , the European Union and Japan also approved the drug for the treatment of adult patients with moderate to severe atopic dermatitis, who were candidates for systemic therapy.
baricitinib 2-mg is prescribed to treat adult patients with moderately to severely active RA who previously had an inadequate response to one or more tumour necrosis factor (TNF) antagonist therapies.
Side effects of baricitinib include serious infections, such as tuberculosis (TB), invasive fungal infections, including candidiasis and pneumocystosis, which may lead to hospitalisation or death.