Lilly/Incyte To Re-File Baricitinib NDA Faster Than Expected

Eli Lilly & Company (NYSE:LLY) and partner Incyte Corporation (NASDAQ:INCY) announced that they will re-submit the new drug application (NDA) for its rheumatoid arthritis (RA) drug, baricitinib much faster than previously expected. The NDA is expected to be re-submitted in January next year.

In July, Lilly had said that the NDA resubmission for baricitinib will not occur this year and will be delayed by a minimum of 18 months. At that time, Lilly had said that it will evaluate options for resubmission, including further discussions with the FDA or conducting an additional clinical study.

In the latest press release, Lilly/Incyte said that the matter was discussed with the FDA this month. Lilly expects the revised submission, which will include new safety and efficacy data, to be classified by the FDA as a Class II resubmission. A decision from the FDA is therefore expected in six months. Importantly, a new clinical study will not be required.

Shares of Incyte were up more than 10% on Wednesday while that of Lilly were up around 2.5%. So far this year, Lilly’s share price has risen 6.8% compared with an increase of 11.3% for the industry.

The FDA had issued a complete response letter (CRL) for baricitinib earlier this year in April. At that time, the agency had told the companies that it is unable to approve baricitinib NDA in its current form. The FDA had asked for additional clinical data to determine the most appropriate doses as well as to further characterize safety concerns across treatment arms.

Baricitinib, a once-daily oral medication, is already marketed in the EU by the trade name of Olumiant. The drug generated sales of $4.8 million in the second quarter of 2017 and $1.9 million in the first quarter.

Baricitinib is also being studied in phase II studies for the treatment of atopic dermatitis and systemic lupus erythematosus while the phase III program for psoriatic arthritis is expected to begin next year.

The RA market is highly crowded given the presence of treatments like Humira and Xeljanz among others. The latest entrant in this crowded market is Sanofi (PA:SASY), Inc. (NYSE:SNY) and Regeneron Pharmaceuticals, Inc.’s (NASDAQ:REGN) , Kevzara, which was launched in the U.S. in June

Lilly carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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