Lilly awaits FDA review of new arthritis treatment
pharmafile | January 20, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Eli Lilly, FDA, Incyte, NDA, baricitinib, lilly, new drug application, rheumatoid arthritis
Eli Lilly has submitted a new drug application (NDA) to the FDA for baricitinib as a treatment for moderate-to-severe rheumatoid arthritis (RA).
The drug, an oral once-daily JAK1 and JAK2 inhibitor, was licensed from Delaware-based Incyte Corporation in 2009, with an agreement that Incyte would receive milestone payments based on certain conditions being met. One such payment related to NDA submission, meaning Incyte receive will $35 million from Lilly immediately.
If baricitinib is granted US regulatory approval, Incyte will receive a further milestone payment of $100 million, and could earn additional global regulatory as well as sales-based milestone payments for the drug.
David Ricks, president of Lilly biomedicines, noted the NDA was backed up by data from a ‘rigorous Phase III program’. In November, Lilly announced results from the year-long RA-BEAM study, which compared baracitinib’s performance to AbbVie’s blockbuster Humira (adalimumab) in 1,305 patients with active, moderate to severe RA despite ongoing treatment with methotrexate. In this trial, Lilly’s drug outperformed Humira in ACR20, ACR50 and ACR70 response rates- which measure the severity of RA symptoms including swollen and tender joints.
If approved, Lilly will be hopeful that baracitinib can become a top seller in its own right, particularly as AbbVie’s drug loses its exclusivity patent in the US at the end of 2016.
Baricitinib is currently also in Phase II development for psoriasis, diabetic nephropathy, atopic dermatitis and systemic lupus erythematosus.
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