分析家因FDA延迟批准而担忧(上)
LONDON (Reuters Health) - The US Food and Drug Administration approved only 27 drugs in 2000, its lowest output since 1995, raising concerns that the agency may delay the approval of new, high-profile drugs, according to analysts at Lehman Brothers.
The analysts quipped that FDA could stand for "Fully Delayed Approvals."
In a report identifying companies and compounds potentially at risk of delay or rejection under a tougher regulatory environment, the analysts quote IMS Health data showing that the FDA's average approval time was 17 months last year, six months longer than in 1998.
Last week's report was written before numerous healthcare stocks fell on Tuesday on news that the FDA had asked Novartis and Genentech to provide more data on asthma drug Xolair and an FDA panel had voted against recommending for approval Guidant Corp.'s Contak CD pacemaker for heart failure.
Other products in FDA limbo include Novartis' irritable bowel drug Zelnorm, for which the company recently received a "non approvable" letter until additional safety is submitted to the agency. GlaxoSmithKline also said that it is still in talks to decide whether its irritable bowel syndrome drug Lotronex should be allowed back on the market.
In addition, the FDA told Eli Lilly in June it needs more time to review the firm's novel sepsis drug Xigris, and earlier this year it asked Dutch group Akzo Nobel to carry out additional studies on its osteoporosis drug Xyvion.
The Lehman report said that it is too early to say whether these delays are the result of a "headless" FDA, a policy shift, increasing conservatism of FDA members or product-specific issues. But whatever the reasons, it warned, "Increasingly we expect more data to be required to support studies."
It added, "A significant concern is for companies that, having already started their phase lll studies, could now suspect that they are not sufficiently powered to produce the data. They may have little choice but either to risk it or start additional phase lll studies that potentially could add at least a year to their scheduled filing dates. If a company does add studies primarily for the US regulators, it is certain that the EU will ask for the data as well, in effect delaying [approval in] both Europe and the US.", http://www.100md.com
The analysts quipped that FDA could stand for "Fully Delayed Approvals."
In a report identifying companies and compounds potentially at risk of delay or rejection under a tougher regulatory environment, the analysts quote IMS Health data showing that the FDA's average approval time was 17 months last year, six months longer than in 1998.
Last week's report was written before numerous healthcare stocks fell on Tuesday on news that the FDA had asked Novartis and Genentech to provide more data on asthma drug Xolair and an FDA panel had voted against recommending for approval Guidant Corp.'s Contak CD pacemaker for heart failure.
Other products in FDA limbo include Novartis' irritable bowel drug Zelnorm, for which the company recently received a "non approvable" letter until additional safety is submitted to the agency. GlaxoSmithKline also said that it is still in talks to decide whether its irritable bowel syndrome drug Lotronex should be allowed back on the market.
In addition, the FDA told Eli Lilly in June it needs more time to review the firm's novel sepsis drug Xigris, and earlier this year it asked Dutch group Akzo Nobel to carry out additional studies on its osteoporosis drug Xyvion.
The Lehman report said that it is too early to say whether these delays are the result of a "headless" FDA, a policy shift, increasing conservatism of FDA members or product-specific issues. But whatever the reasons, it warned, "Increasingly we expect more data to be required to support studies."
It added, "A significant concern is for companies that, having already started their phase lll studies, could now suspect that they are not sufficiently powered to produce the data. They may have little choice but either to risk it or start additional phase lll studies that potentially could add at least a year to their scheduled filing dates. If a company does add studies primarily for the US regulators, it is certain that the EU will ask for the data as well, in effect delaying [approval in] both Europe and the US.", http://www.100md.com