In a surprise decision, the U.S. Food and Drug Administration (FDA) didn’t approve the new Eli Lilly & Co. and Incyte Corp. RA drug
The new medication, baricitinib (Olumiant), was not approved in the USA despite already being approved in Europe. According to a press release by Eli Lilly, the FDA noted safety concerns in the complete response letter (CRL) issued to the company.
Eli Lilly “disagree with the agency’s conclusions” that additional clinical data are needed to determine appropriate dosing and further analyze safety concerns within the treatment arms of the clinical trials. The drug buy windows 10 key will be resubmitted for approval based on further discussions with the FDA.
Christa Shaw, the president of Lilly Bio-Medicines, remains optimistic about the future of the medication though. “We remain confident in the benefit/risk of baricitinib as a new treatment option for adults with moderate-to-severe RA,” she said. Originally, the New Drug Application (NDA) was submitted in January 2016 and was granted a three-month extension for additional review at the beginning of this calendar year.
Reason for baricitinib optimism
Baricitinib is a once-daily oral pill that, in addition to being studied for rheumatoid arthritis benefit, is also in trials for atopic dermatitis and lupus. It works by blocking two Janus kinase (JAK) enzymes, which are “proteins implicated in the development of inflammation.” It is known as a JAK inhibitor.
Lilly and Incyte performed four Phase 3 clinical trials for the medication, including one where it was compared to AbbVie’s Humira (adalimumab). Humira is a injectable biologic – which is another reason why the once-daily pill, baricitinib, is exciting.
In the trial published in the New England Journal of Medicine, baricitinib performed better than Humira and placebos as measured at 12 weeks. 70% of people treated with baricitinib showed improvement in joint swelling and other American College of Rheumatology measures microsoftproductssettlement of disease activity. Only 61% of people treated with Humira experienced benefit.
Next steps
The companies will work the FDA to find out what is necessary for drug approval. Some analysts suspect that the FDA may want data on lower doses, and it in unclear if the benefits will hold up at 2 mg doses. The European Medicines Agency (EMA) approved both 2 mg doses and 4 mg doses.