Bristol-Myers Squibb and AstraZeneca’s experimental diabetes pill poses no excessive heart risk and could be a promising treatment, a US advisory panel ruled on Wednesday.
But the Food and Drug Administration’s panel of outside experts also said more data would be needed after approval to weigh any possible long-term risks, especially in older patients and others more likely to have heart problems.
“This might wind up being a great drug, but we don’t know that yet,” said panellist Marvin Konstam, a cardiologist at Tufts University School of Medicine. Still, he added, “I think this agent has promise to differentiate itself.”
The companies are hoping to market the drug under the brand Onglyza to compete against Merck & Co’s blockbuster drug Januvia. Both drugs aim to enhance the body’s ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors.
Company officials said even though there are numerous other diabetes therapies on the market, some can cause weight gain and other complications. Many patients are also still not reaching their optimal blood sugar levels, they said.
“There’s substantial unmet need for new treatments for type 2 diabetes,” Bristol vice president Robert Wolf told the panel, which is meeting for two days to discuss new options.
Shares of Bristol gained 1.7% to close at $21.97 on the New York Stock Exchange. AstraZeneca shares rose 1.3% to $35.90, also on the NYSE.
At issue is whether the companies’ data meets new FDA guidelines calling for closer scrutiny of possible heart damage, which came out in December after Bristol had already sought approval.
Analysts have said the two-day meeting is a key indicator of how the agency will implement its new measures and bring new products to the $6bn diabetes market. Nearly 24 million people in the United States, or nearly 8% of the population, have the condition, government statistics show.
FDA officials targeted heart safety after researchers linked GlaxoSmithKline’s diabetes pill Avandia to greater heart risks in 2007. A strong warning was added to the drug, although Glaxo says it is as safe as other approved diabetes medicines.
On Thursday the FDA panel will discuss Novo Nordisk’s injectable diabetes drug liraglutide, a GLP-1 analog the company aims to sell under the brand name Victoza.
For Onglyza, all but two of the 12 panellists said data did not show a high risk of strokes, heart attacks or other heart problems. The drug is also known as saxagliptin.
The data “certainly convinced me that there’s not big harm,” said panellist Michael Proschan, a statistician at the National Institutes of Health.
But several members expressed concern that, if approved, the FDA should require information on the drug’s label, noting the lack of information for patients already at risk for heart trouble, including the elderly.
Bristol said its studies included 5,346 patients, mostly those in their mid-50s who had few heart problems and were recently diagnosed.
In a 12-0 vote, the panel said the agency should require further study of saxagliptin, even if it wins approval.
Dr Curtis Rosebraugh, head of one of the FDA’s drug evaluation offices, said the agency was ‘asking sponsors to beef up their enrolment’ for such post-approval trials. Drugmakers should study ‘populations that reflect the general population’, he told reporters after the meeting.
FDA officials will consider the panel’s recommendation before deciding whether or not to approve the product. The companies expect a decision by 30 April.
By Susan Heavey.