Indianapolis-based Eli Lilly & Company and Incyte Corp announced that Lilly has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of baricitinib, a once-daily oral compound for the treatment of moderate-to-severe rheumatoid arthritis (RA).
RA is an autoimmune disease characterized by inflammation and progressive joint destruction. Approximately 23 million people suffer from this condition worldwide, and nearly three times as many women as men have RA. Current treatment includes using oral disease-modifying anti-rheumatic drugs like methotrexate, besides non-steroidal anti-inflammatory drugs and injectable biological response modifiers that target selected mediators.
Baricitinib is in late-stage clinical studies for inflammatory and autoimmune diseases. Currently, baricitinib is in Phase 3 clinical development for RA and Phase 2 development for systemic lupus erythematosus (SLE), atopic dermatitis, diabetic nephropathy and psoriasis.
The last Phase 3 clinical trial of baricitinib in patients with moderate-to-severely active rheumatoid arthritis with inadequate responders to methotrexate will soon join the three completed Phase 3 trials in other patients: inadequate responders to biologic DMARDs; inadequate responders to conventional disease-modifying anti-rheumatic drugs; and patients who have not been on DMARD treatment.
As a result of the NDA submission, Incyte will now receive a milestone payment of $35 million from Lilly. If baricitinib is granted approval, Lilly will pay an additional $100 million to Incyte as well as other additional sales-based and royalties earnings later on.
Lilly Bio-Medicine’s President David Ricks said in a press release, “Lilly’s collaboration with Incyte has produced a rigorous phase 3 program and, if approved, the potential of a promising new treatment option for people with RA.”
Incyte is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics for oncology and inflammation. Lilly discovers and brings medicines to people around the world, along with improving the understanding and management of disease.
A New Drug Application (NDA) is a pathway through which pharmaceuticals formally propose to the FDA a new therapeutic drug for sale and marketing in the U.S. The NDA must include data gathered during the Investigational New Drug (IND) animal and human clinical studies. Information must include::
- Adequacy of methods used in manufacturing the drug to preserve its quality, identity, strength and purity;
- Content assessment in the drug’s proposed labeling;
- Drug safety and efficacy in its proposed use, and whether the benefits outweigh the risks.