Eli Lilly and Incyte faced a bad Monday with shares of both company going down after FDA rejected baricitinib, a treatment for rheumatoid arthritis.
Christi Shaw, president of Lilly Bio-Medicines, said in a statement: “We will continue to work with the FDA to determine a path forward and ultimately bring baricitinib to patients in the U.S.”. FDA asked for more clinical data to clarify safety concerns and to determine what dose should be given to patients.
The analysts called baricitinib’s rejection a “surprising, and significant, setback for Lilly.”
“Overall, we highly doubt that the stated FDA concerns could be addressed without new clinical trials; therefore, we believe the timing for Bari’s U.S. RA launch is most likely pushed back at least three years,” BMO said in a Monday note, adding it lowered its 2017 global sales forecast on the company
Wall Street analysts believed the treatment would have generated more than $1 billion in sales by 2020 if it had been approved, according to Bloomberg data.
The rejection could be on the other side positive for AbbVie, which makes the world’s top-selling arthritis injection Humira, and which is also developing a pill to rival Baricitinib.
Source: CNBC, The Irish Times