The U.S. FDA denied approval of the diabetes drug Byetta, sold by Amylin Pharmaceuticals & Eli Lilly, the FDA reasoned in a letter sent to the 2 companies - more information is needed about the drug’s product label, risk-management plan and manufacturing process.
Amylin responded right away and it aims to submit its response to the FDA “in the next few weeks.” Despite the delay in approval, the FDA letter was seen as good news by the market because the agency didn’t request any additional clinical data or analysis of already submitted data.
Amylin shares, which were initially down about 1 percent, went up about 13 percent to $23 in premarket trade. Eli Lilly shares were unchanged at their Friday’s close of $35.93 on the New York Stock Exchange.
In a joint statement, the companies said the FDA did not make any requests related to the regulator’s pre-approval inspection of Amylin’s Ohio manufacturing facility.
U.S. regulators had found shortcomings at the Amylin manufacturing plant during an inspection in December, but the companies said all observations made by the FDA related to that inspection have been addressed.
Byetta, whose chemical name is exenatide and has annual sales of about $700 million, is used to treat type II diabetes — the more common form of diabetes which is closely linked to obesity.
Amylin Pharmaceuticals and its partners Eli Lilly and Alkermes are going to have to wait a while to celebrate. The FDA has delayed an application from San Diego-based Amylin (NASDAQ: AMLN) and Indianapolis-based Eli Lilly to start marketing their new diabetes drug, the first once-weekly shot, as a more convenient alternative to control blood sugar.
The silver lining is that the drug, exenatide once-weekly, doesn’t need to pass any new animal tests or clinical trials before it can be cleared for sale in the U.S., the companies said today in a statement. The FDA’s “complete response letter” raises issues around finalizing the prescribing information that guides physicians, along with a Risk Evaluation and Mitigation Strategy (REMS) program and “clarification of existing manufacturing processes,” the companies said. The FDA raised some issues at a December inspection of Amylin’s Ohio manufacturing plant, although those have been addressed, the companies said.
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