Diabetes drug alogliptin fell short of U.S. Food and Drug Administration approval on Wednesday, dealing a blow to the hopes of Takeda Pharmaceutical (TYO:4502) and its partner, Furiex Pharmaceuticals (NASDAQ:FURX).
The complete response letter means Takeda will need to come up with more data if it wants to try again for FDA approval on its type 2 diabetes drug. Diabetes drug development has hit some stumbling blocks since scrutiny on GlaxoSmithKline‘s (NYSE:GSK) Avandia reached a peak in 2010. Here are some key regulatory actions in recent diabetes drug history.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
July 2010: An FDA advisory panel holds a two-day meeting to discuss safety issues surrounding GSK’s Avandia, which in 2007 received a black box warning stating that the drug may cause heart attacks. The panel’s discussion divides the 33-member body. Twelve members vote to remove Avandia from the market; 10 vote for continued sale but with a revised label and possible restrictions; seven vote to add warnings; and three vote for no change at all. The panel also votes 21-3 that Avandia posed a higher risk than Takeda diabetes drug Actos.
September 2010: Two months after an FDA advisory panel considers the health risks associated with Avandia, the FDA announces it will significantly restrict use of the diabetes drug. As a result, Avandia can only be used by type 2 diabetes patients who cannot control their diabetes on other medications. The FDA said that the restriction is a response to data that suggests the drug increases the risk of heart attack and stroke.
January 2011: MannKind‘s (NASDAQ:MNKD) Afrezza, developed as an inhaled form of insulin that is quickly absorbed by the lungs. Afrezza, developed to treat type 1 and type 2 diabetes, receives a complete response letter from the FDA, the company’s second such letter. The FDA asks for additional clinical studies on the company’s next-generation inhaler with at least one trial comparing the new inhaler with an earlier version inhaler in order to get a head-to-head comparison.
July 2011: Takeda files two new drug applications with the FDA for alogliptin, one for marketing approval of the drug and another for approval of alogliptin in combination with pioglitazone, a Takeda diabetes drug currently marketed as Actos. Previous drug applications for alogliptin were met with complete response letters in 2009 as the FDA asked for more cardiovascular safety data. This time, Takeda says it believes interim results from a cardiovascular outcomes study will be enough to support approval.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
November 2011: A FDA program to restrict access to Avandia launches. Doctors who want to continue prescribing the drug and patients who want to continue receiving it must enroll in the program by Nov. 17, 2011. After Nov. 18, 2011, Avandia is no longer available in retail pharmacies. The only way patients can obtain the drug is by mail order from specially certified pharmacies participating in the program.
Jan. 19, 2012: The FDA issues a complete response letter to AstraZeneca (NYSE:AZN) and Bristol-Myers Squibb (NYSE:BMY) on the the new drug application for dapagliflozin, an investigational treatment for type 2 diabetes in adults. The FDA asked for more data to evaluate the benefits and risks of the treatment. Last July, an FDA advisory committee voted against drug approval amid concerns about breast and bladder cancers seen in patients taking the drug. Dapagliflozin would be a new class of diabetes drugs. Rather than using insulin to regulate blood sugar, dapagliflozin reduces excess blood sugar by causing it to be excreted in the urine. The companies say they may need to conduct additional clinical trials.
Feb. 17, 2012: Merck (NYSE:MRK) receives an FDA warning letter for failing to conduct timely and complete post-marketing studies on blockbuster diabetes drugs Januvia and Janumet. The FDA wanted a pancreatic safety study on the active ingredient in both drugs. Although Merck did submit data, the FDA said it was not sufficient.
April 25, 2012: The FDA issues a complete response letter for Takeda’s drug application for Alogliptin. Takeda and Furiex do not disclose specific FDA concerns but say the agency had requested more data that Takeda believes it can supply from post-marketing studies and ongoing clinical research. A cardiovascular outcomes study is expected to have final results in 2014.
[Image from stock.xchng user svilen001]
