Safety concerns surrounding the diabetes drug <"https://www.yourlawyer.com/topics/overview/byetta_pancreatitis">Byetta have slowed its sales, forcing Amylin Pharmaceuticals to cut a quarter of its work force.
Byetta, which is jointly marketed by Amylin and Eli Lilly, was approved by the Food & Drug Administration (FDA) in 2005 to help type 2 diabetics better control blood sugar when other drugs were not adequate. The twice-daily injection is a synthetic form of a lizard hormone that boosts the production of insulin. Insulin is vital to controlling blood sugar levels.
Amylin sales have been disappointing all year. Then, on August 18, the FDA said that Byetta had been linked to 6 cases of hemorrhagic or necrotizing pancreatitis in patients taking Byetta since its October alert. All patients required hospitalization, two patients died and four patients were recovering at time of reporting. Byetta was discontinued in all 6 cases. Then, on August 26, Amylin announced that four additional fatalities had been confirmed in Byetta patients suffering from milder forms of pancreatitis.
The problems with Byetta have raised doubts about Amylin’s ability to assure approval of a long-acting version of the drug. The new version of Byetta would be taken once-weekly. Because of its long-acting nature, once-weekly Byetta cannot be quickly removed from the body, which would be a problem for a patient who developed pancreatitis. In most instances where Byetta patients develop pancreatitis, the problem subsides once treatment is halted. That would not likely be the case with the long-acting version.
In a filing with the Securities and Exchange Commission (SEC) earlier this month, Amylin revealed that the FDA had rejected data from studies meant to show that new Byetta batches made by partner Alkermes were equivalent to batches made at Amylin’s Ohio facility. If Amylin has to conduct an additional study, it would likely delay its plans to ask for approval by the middle of 2009.
The layoffs announced by Amylin this week involve 340 staffers, and will leave the San Diego company with 1800 employees. Amylin says the move will save $100 million a year.
In a statement, Amylin said it expects Byetta sales to rebound, and the company is currently working with the FDA to update the drug’s safety labeling. Amylin is hoping the safety update will not take the form of a black box – the FDA’s toughest safety warning – which could further depress sales of Byetta.
