FDA Extends NDA Review Period for New RA Treatment Expected to Compete with Humira

The FDA has extended the review period of the New Drug Application (NDA) for baricitinib, Eli Lilly/Incyte Corporation’s once-daily investigational oral rheumatoid arthritis (RA) treatment, an additional 3 months beyond the Prescription Drug User Fee Act’s 1-year goal for reviewing NDAs. The additional time was needed to review more data submitted by Lilly in response to information requests made by the agency.

Some analysts considered baricitinib a potential “blockbuster” because it has shown clinical superiority over Humira (adalimumab), has a strong safety profile, and is an oral, rather than injection, RA treatment that was expected to be close to launch and possibly available before Humira biosimilars enter the market.

The NDA for baricitinib was submitted to the agency for review in January 2016. However, the FDA determined that submission of additional information constituted a Major Amendment to the NDA, resulting in the 3-month extension. Baricitinib was also submitted for regulatory review in the European Union and Japan in early 2016. The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use issued a positive opinion of the drug in December 2016, recommending its approval. If approved in Europe, it would be marketed there as Olumiant. The drug is also being studied in phase II trials for atopic dermatitis and systemic lupus erythematosus, and a phase III trial for patients with psoriatic arthritis is expected to begin in 2017.

Baricitinib is an oral JAK (Janus kinase) inhibitor in development for inflammatory and autoimmune diseases. There are four known JAK enzymes, and JAK-dependent cytokines have been implicated in the pathogenesis of a number of inflammatory and autoimmune diseases, suggesting that JAK inhibitors may be useful for the treatment of a range of inflammatory conditions, according to Lilly. “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,” said J. Anthony Ware, MD, senior vice president, product development, and interim president of Lilly Bio-Medicines.