Today we might glimpse the U.S. Food and Drug Administration’s thoughts on approving new type 2 diabetes drugs in a post-Avandia world.
Nesina, a Takeda Pharmaceutical (TYO:4502) compound licensed from Furiex Pharmaceuticals (NASDAQ:FURX), is set for a prescription drug user fee act (PDUFA) decision today. The drug candidate, also known as alogliptin, was developed to treat type 2 diabetes. Nesina’s U.S. approval would put Morrisville, North Carolina-based Furiex in line for a $25 million milestone payment. Furiex could earn an additional $33 million in sales-based milestone payments.
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An FDA approval decision has been a long time coming. So far, Takeda’s efforts have generated two complete response letters seeking additional cardiovascular safety information and a delay of FDA action on the latest submission — today’s approval date was originally scheduled for January.
Furiex and Takeda began working together on Nesina in 2005, when Furiex was the drug development arm of clinical research organization PPD. PPD spun off Furiex as a separate company in 2010, the same year that Takeda secured Japanese approval for Nesina. But the compound’s U.S. prospects fell victim to unfortunate timing. Nesina’s 2008 new drug application with the FDA coincided with growing regulatory scrutiny on heart risks for diabetes drugs, particularly Avandia. That former GlaxoSmithKline (NYSE:GSK) blockbuster diabetes drug became the center of federal hearings on alleged cardiovascular risks and later, multiple lawsuits that claimed the drug was responsible for deaths.
By the end of 2008, the FDA developed new cardiovascular guidance for drugs treating type 2 diabetes. The guidance applied to all diabetes drugs under development. The higher scrutiny on diabetes drugs gave more than a few drug developers pause. California biotechnology company Plexxikon is held in high regard for developing skin cancer drug Zelboraf, whose success led to Plexxikon’s 2011 acquisition by Daiichi-Sankyo in a deal valued at just shy of $1 billion. But Plexxikon’s initial target was diabetes. Plexxikon’s diabetes compound showed promise in safety and efficacy. But the company stopped pursuing development of a diabetes treatment because of the economic risks of developing a diabetes drug.
The 2009 complete response letters sent to Takeda sought more cardiovascular safety information on Nesina. Confident it could address the FDA’s concerns, Takeda last year filed two new drug applications for the drug candidate. The company is seeking approval of Nesina as a diabetes treatment on its own, in conjunction with diet and exercise. The company also applied for approval of Nesina with another Takeda drug, Actos, which treats insulin resistance. The FDA approved Actos in 1999. The Nesina/Actos combination drug has approval in Japan, where it is marketed as “Liovel.”
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Takeda and Furiex have been waiting four years for a Nesina approval decision in the United States, a process that represents a significant investment of time and money. Given the FDA’s greater scrutiny on diabetes drugs, other diabetes drug developers will be watching the Nesina approval decision closely to gauge whether their efforts are also worth the time and money.
