Positive CHMP opinion is based on a comprehensive submission including data from the pivotal AURORA 1 efficacy study and the AURORA 2 continuation study, demonstrating voclosporin to be safe and well
It wasn't long ago that Bristol Myers Squibb ran the numbers on potentially buying Acceleron Pharma, but that deal didn't come together, and the biotech eventually sold to Merck for $11.5 billion. Now, BMS has its eyes on another target, Bloomberg reports.
FDA announces drug trial information for new lupus and chronic heart failure medications Food and Drug Administration (generic). (Source: CNN) By KOLD News 13 Staff | February 10, 2021 at 3:29 PM MST - Updated February 10 at 3:29 PM
TUCSON, Ariz. (KOLD News 13) - Today, the U.S. Food and Drug Adminstration announced the information for two new medications that recently underwent clinical trials.
The first is called
Lupkynis (loop kye’ nis) and is used to treat patients with active lupus [nephritis], an inflammation of the kidneys that is caused by a chronic auto-immune disease.
According to the FDA, patients who received the drug for one year acheived major reduction in kidney inflammation.