Novo Nordisks Diabetes Drug May Avoid Takedas Travails At Fda
The Danish companys studies, involving more than 6,500 patients, show the experimental medicine meets tougher U.S. Food and Drug Administration requirements put in place after the research began, Chief Science Officer Mads Krogsgaard Thomsen said in a telephone interview. Novo Nordisk said the U.S. hasnt told the company that it needs more studies to meet the new requirements.
That may help the Bagsvaerd, Denmark-based drugmaker avoid the travails of Takeda Pharmaceutical Co., which is developing a similar diabetes treatment. The Japanese companys shares fell the most in more than two decades in Tokyo trading on March 9 after saying it didnt have enough data on its drug alogliptin to satisfy FDA demands. AstraZeneca Plc and Bristol-Myers Squibb Co. are also seeking approval for another type of diabetes drug.
“Given the Takeda experience, people are more cautious,” said Jack Scannell, a Sanford C. Bernstein & Co. analyst in London. “Weve gone from a world where people thought liraglutide would sail through the advisory committee to a world where people are aware its not a dead certainty.”
Scannell expects the drug to “scrape through” the advisory panel meeting, win FDA approval and generate a peak of $1 billion in U.S. revenue by 2013. Its sales potential is limited by gastrointestinal side effects that may lead some patients to opt against it, he said in a telephone interview.
Shares Move
Novo Nordisks shares rise and fall with news about liraglutide. On Sept. 8, the stock rose the most in almost a month after tests showed the drug reduced weight and improved blood-sugar levels. The stock fell 1.2 percent on Nov. 19 after the FDA postponed its advisory panel meeting on liraglutide by a month. Novo Nordisk rose 10 kroner, or 3.9 percent, to 268.50 kroner in Copenhagen trading yesterday.
None of the current studies were designed with the agencys guidance in mind, said Mary Parks, head of the FDAs Division of Metabolism and Endocrinology Products, in a telephone interview. Still, some companies may have been lucky and included enough patients to confidently rule out the risk, she said.
“Each company has to look at their program, at what they have already done, to see if it is enough,” Parks said.
The FDA is requiring manufacturers of all new diabetes drugs to prove they arent tied to an increase in heart attacks and deaths. The guidelines, released in December, come after the agencys mistakes in handling GlaxoSmithKline Plcs Avandia. Once the worlds best-selling diabetes drug, Avandia was linked to heart attacks in 2007 after eight years on the market. While the agency knew about the risks, they didnt become public until an outside researcher brought it to public attention.
April 1 Meeting
The first use of the guidelines will come April 1, when an FDA advisory panel reviews AstraZeneca and Bristol-Myerss saxagliptin. The drug belongs to a class of medicines called DPP-4 inhibitors that includes Januvia, Merck & Co.s drug with $1.4 billion in annual sales. They work differently from other medicines on the market by spurring insulin production and restricting glucose levels.
AstraZeneca and Bristol-Myers said their saxagliptin studies are comprehensive and show no signs of cardiovascular risk. They declined to give details before the FDA meeting of the studies, which involved more than 5,000 patients. The agency hasnt told them they need more research, the companies said.
Pancreas Stimulated
On April 2, the FDA panel will review Novo Nordisks liraglutide, from the same class of medicines as Amylin Pharmaceuticals Inc. and Eli Lilly & Co.s Byetta. The drugs imitate a hormone called GLP-1 and stimulate the pancreas to produce more insulin after meals. The so-called incretin mimetics are injected and compete against pills like Januvia.
The FDA asked companies that are still designing their studies to include patients with advanced disease, old age or kidney disease, and to extend the research to a minimum of two years from the standard three to six months to resolve heart- safety issues.
Even without the extra length and risky patients, the Novo Nordisk data show the drug doesnt increase heart risks and may lower them, Novo Nordisks Thomsen said. Following the FDAs request for a statistical analysis that includes the worst-case scenario, the company ruled out an 80 percent increase in heart risk — meeting the agencys new guidelines, he said.
“In spite of the fact that our statistical approach hasnt been designed for this analysis, we did it,” Thomsen said. The absolute risk with liraglutide is equal to or lower than comparison drugs used in the studies, and the upper limit doesnt exceed the levels proposed by the FDA, he said.
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