FDA Wants More Byetta Studies: Analyst
2 CommentsBy Ed Silverman // December 24th, 2009 // 8:10 am
File this under sticking point. The agency wants Amylin Pharmaceuticals to run more studies of its Type 2 diabetes drug, which was approved two months ago as a stand-alone treatment, due to safety concerns over pancreatitis, according to an investor note issued yesterday by Citigroup analyst Yaron Werber.
At the time of the Oct. 30 approval, Amylin indicated prescribing info would warn about pancreatitis in patients with severe kidney disease. You may recall the twice-daily injectable drug was linked to six deaths last year (see here), which hurt sales. However, the Amylin statement didn’t mention additional studies.
Werber wrote that he obtained a copy of the FDA’s approval letter (here it is) and the agency considers post-marketing reports of acute pancreatitis, acute renal failure and thyroid neoplasm to be new safety info. Amylin and Lilly, its Byetta marketing partner, issued a statement saying most of the studies are already under way and have not shown any increased risk of acute pancreatitis. Not surprisingly, Werber’s note caused Amylin stock to drop; shares fell nearly 10 percent yesterday.
will
So, the big question that seems to be on lot of folks mind is, just how big of a position does Werber hold in NVO and MRK?
I’m sure the SEC is already looking in to it after his gum flapping yesterday
patrons99
According to an FDA Byetta Safety Update for Healthcare Professionals,
“On October 30, 2009, FDA approved a Risk Evaluation and Mitigation Strategy (REMS) for Byetta. The REMS was part of an approval for a new indication of Byetta to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Previously Byetta was only approved for use in combination with other anti-diabetic drugs.”
“Over 7 million prescriptions for Byetta have been dispensed since it was first approved by FDA in 2005. Therefore, while these adverse events are very serious, the number of reported cases of acute pancreatitis, hemorrhagic and necrotizing pancreatitis, and altered kidney function represent a small percentage of the total number of patients who have used Byetta.”
“Additionally, the sponsor, Amylin Pharmaceuticals Inc, is being required to conduct six post-marketing studies (Postmarketing Requirements [PMRs]) to help further define the mechanism, incidence, and risk factors for the development of acute pancreatitis, including hemorrhagic and necrotizing pancreatitis, associated with the use of Byetta, as well as to explore a potential signal of a serious risk of thyroid cancer and pancreatic cancer.”
Oh really?…”a potential signal of a serious risk of thyroid cancer and pancreatic cancer” As if hemorrhagic pancreatitis isn’t a great enough risk to justify removal from the market place. Why would anyone risk prescribing this drug?