Wyeth to Provide More Data on Drug
Wyeth (WYE) said Tuesday that the Food and Drug Administration wants more information about an experimental drug to prevent osteoporosis before it will grant full clearance for the treatment.
The announcement of the FDA's conditional approval wasn't a surprise because Wyeth had predicted such a delay last week. Known scientifically as bazedoxifene, the drug will be sold under the brand name Viviant.
The FDA's decision "is in line with our expectations," said Dr. Gary Stiles, executive vice president and chief medical officer of Wyeth's human-drug business. "We will work closely with the FDA ... and are moving forward with plans to seek an additional indication for the treatment of postmenopausal osteoporosis later this year."
Wyeth must achieve several goals to secure final approval. The FDA has to receive and analyze additional safety and efficacy data from a recently completed clinical trial. The agency will be looking at bone-fracture data, and Wyeth said last week the review could take six months.The FDA also must sign off on manufacturing and testing facilities for the drug at Wyeth's plant in Puerto Rico. The plant has been under FDA scrutiny since May 2006 for manufacturing problems. Until the FDA approves Wyeth's plan to fix the shortcomings, the company can't make new drugs there. "We believe the situation ... will be resolved without affecting the timing of new product launches," Wyeth said. The stock closed at $55.53, down 20 cents.
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