STAT+: Pharmalittle: FDA declines to approve higher dose version of Regeneron eye drug; FDA warns wholesaler over counterfeit HIV pills
The FDA declined to approve a higher-dose version of a Regeneron Pharmaceuticals drug called Eylea.
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The U.S. Food and Drug Administration declined to approve a higher-dose version of a Regeneron Pharmaceuticals drug called Eylea for treating a disease that is the leading cause of blindness among the elderly, Reuters writes. The move comes as Regeneron seeks to defend the blockbuster treatment against a fast-gaining rival. The agency issued a complete response letter that cited issues with a third party company that was contracted to fill the higher dose of the medicine. The letter did not identify any issues with clinical efficacy or safety, trial design, labeling, or drug substance manufacturing, and no additional clinical data or study have been requested.
A year after two major drugmakers sued a wholesaler for its alleged role in distributing counterfeit HIV pills, the U.S. Food and Drug Administration warned the same company for failing to ensure that “suspect” medicines did not enter the marketplace, STAT writes. In a June 8 letter, the agency rebuked Safe Chain Solutions for violating a federal law designed to bolster the integrity of the pharmaceutical supply chain. Gilead Sciences and Johnson & Johnson had filed separate lawsuits accusing Safe Chain — as well as several little-known distributors and pharmacies — of disseminating countless bottles of fake HIV medicines and incorrect pills, including antipsychotics.
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