Astellas' hopes for a quick U.S. approval for Advagraf--a follow-up, new and improved version of the kidney transplant drug Prograf--have run into a serious obstacle. The drug company says that the FDA has asked for more information on the drug, a once-daily immunosuppressant drug that the company needs to take a slot in its lineup now filled by Prograf. Prograf loses its patent protection in April. The regulatory demand, though, will delay any approval by at least six months. Regulators want to see more data on efficacy and safety for Advagraf.
This is one request that is likely to get as quick a response as the researchers can muster. Prograf has a big market in the U.S.--used in roughly five out of every six kidney transplants--and accounts for about 10 percent of Astellas' revenue.
- read the article from the Guardian