FDA顾问团认可Amgen公司的药物治疗类风湿性关节炎(下)
Others also observed that the treatment eventually might prove to slow or halt the progression of the disease in future trials.
The committee decision may spell the end of Amgen's 3-year long struggle to get Kineret approved. The Thousand Oaks, California-based concern originally attempted to file for the approval of Kineret in 1999, but at that time, the FDA concluded that there was insufficient data to support its approval.
Now with the endorsement of the expert committee, Amgen faces much better odds. Although not bound by its experts' advice, the FDA generally follows its committees' recommendations.
If approved, though, Kineret is unlikely to be used as a first-line treatment for the estimated 2.1 million Americans that have RA.
"I would start all my patients on NSAIDs and then methotrexate. But I would use anakinra to treat patients that fail to respond," Dr. Stanley Cohen of the St. Paul Medical Center in Dallas Texas, who acted as a principal investigator for Kineret and a number of the other drugs, told Reuters Health.
Methotrexate is an oral chemotherapy drug that is also often used for the treatment of RA, whose exact causes remain a medical mystery.
SG Cowen Securities analyst Eric Schmidt estimates that Kineret, if approved, could ring up sales of $60 million next year, rising to $160 million in 2004.
In Thursday afternoon trade on the NASDAQ, shares in Amgen rose 0.40 to 60.49., 百拇医药
The committee decision may spell the end of Amgen's 3-year long struggle to get Kineret approved. The Thousand Oaks, California-based concern originally attempted to file for the approval of Kineret in 1999, but at that time, the FDA concluded that there was insufficient data to support its approval.
Now with the endorsement of the expert committee, Amgen faces much better odds. Although not bound by its experts' advice, the FDA generally follows its committees' recommendations.
If approved, though, Kineret is unlikely to be used as a first-line treatment for the estimated 2.1 million Americans that have RA.
"I would start all my patients on NSAIDs and then methotrexate. But I would use anakinra to treat patients that fail to respond," Dr. Stanley Cohen of the St. Paul Medical Center in Dallas Texas, who acted as a principal investigator for Kineret and a number of the other drugs, told Reuters Health.
Methotrexate is an oral chemotherapy drug that is also often used for the treatment of RA, whose exact causes remain a medical mystery.
SG Cowen Securities analyst Eric Schmidt estimates that Kineret, if approved, could ring up sales of $60 million next year, rising to $160 million in 2004.
In Thursday afternoon trade on the NASDAQ, shares in Amgen rose 0.40 to 60.49., 百拇医药