A trio of diabetes drug candidates are affected by a tougher stance at the FDA for this class of drugs, which is focused on cardiovascular risks such as heart attack and stroke. Two of the drugs will be reviewed at early April FDA advisory panel meeting while a third will likely require additional clinical trials.
In December the FDA issued a new guidance document that recommended more stringent clinical trials for diabetes drugs to better assess heart attack and stroke risks. In a change that was effective immediately, the agency said studies should "demonstrate that new antidiabetic therapies do not increase cardiovascular risk in comparison with existing therapies."
The agency is calling for extended diabetes clinical studies to include older and sicker patients at higher risk of having a heart attack or stroke and a longer follow-up period lasting up as long as two years (versus 3-6 months).
1.) Novo Nordisk (NVO): Victoza (liraglutide) NDA for Type 2 Diabetes - April 2-3 FDA Advisory Panel Meeting - (Original PDUFA date was 3/23/09). Victoza (liraglutide) is used once-daily via subcutaneous injection. Liraglutide is a synthetic glucagon-like peptide-1 (GLP-1) and is classified as an incretin mimetic type of diabetes drug.
GLP-1 is a gut-derived regulator of glucose that is released after oral ingestion of carbohydrates or gats. Type 2 diabetics have reduced levels of GLP-1 in response to carbohydrate intake. GLP-1 enhances insulin secretion once it enters the systemic circulation and also increases the synthesis of insulin.
Other effects of GLP-1 include suppression of glucagon secretion, slower gastric emptying (5-10% incidence of nausea), reduced food/caloric intake, and pancreatic beta cell proliferation. Liraglutide does not increase insulin secretion or suppress glucagon secretion when blood glucose levels are low or normal.
2.) Bristol-Myers (BMY) and AstraZeneca (AZN): Onglyza (saxagliptin oral tablets) NDA - A dipeptidyl peptidase-4 (DPP-4) enzyme inhibitor for Type 2 Diabetes -- 4/1/09 FDA Advisory Panel Meeting -- Endocrinologic and Metabolic Drugs Advisory Committee. DPP-4 inhibitors work by increasing the level of incretin hormones in the body which help lower blood glucose levels, with the only marketed product in the class represented by Merck's (MRK) Januvia.
3.) Takeda Pharma (TKPHY.PK): Shares of the largest Asian drug company fell the most in 21 years on concern U.S. approval of its diabetes drug alogliptin, a successor to its top selling diabetes drug Actos will likely be delayed and require additional clinical studies. Although the alogliptin NDA was filed prior to issuance of FDA's December 2008 guidance on new Type 2 diabetes treatments, the FDA will apply these guidelines when reviewing the alogliptin NDA.
Additionally, the FDA does not believe that the amount of existing alogliptin clinical data is sufficient to meet certain statistical requirements in the new guidance. The agency is open to discussions regarding the design of additional CV studies with alogliptin. Alogliptin's Prescription Drug User Fee Act (PDUFA) date - June 26, 2009 - remains unchanged. In December, 2008 the FDA issued "Guidance for Industry: Diabetes Mellitus -- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes".
4.) Genentech (DNA): Avastin (bevacizumab) sBLA - brain cancer (relapsed glioblastoma) -3/31/09 Advisory Panel Meeting -FDA Oncologic Drug Advisory Committee - 5/5/09 is PDUFA decision date deadline.
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