Type 2 oral diabetes drugs from Takeda, Merck and other manufacturers stand to realize sales gains from today's FDA advisory panel review of the GlaxoSmithKline Avandia pill.
With the committee debating whether Avandia should be pulled from the US market due to cardiovascular safety and possibly efficacy, a negative outcome remains a possibility. Analysts say the risk of a decision by FDA or GSK to withdraw Avandia has narrowed in light of recent data. But the panel could also advise strengthening the current “black box” warning. Either scenario could further dissuade endocrinologists and primary care physicians from prescribing Avandia, whose share of total prescriptions fell 32% last year, according to Wolters Kluwer Pharma Solutions.
Who could benefit? Among adults with diabetes, more than half take oral medications only, the Centers for Disease Control and Prevention says. These include oral thiazolidinediones (TZDs), like Avandia and Takeda's Actos, as well as DPP-IV inhibitors like Merck's Januvia and Bristol-Myers Squibb/AstraZeneca's Onglyza. As the only other TZD on the US market, Takeda's Actos has already profited from the Avandia controversy. The drug, which has been shown to lower blood sugar without increasing the risk of heart attack or stroke, saw US wholesale average cost (WAC) sales increase 8.6% last year to $3.2 billion while new prescriptions dipped 3.5%.
The next best-selling oral diabetes brand behind Actos is Januvia, from Merck, with US WAC sales of $1.5 billion last year, a 32% annual increase. Onglyza, meanwhile, is off to a slow start since launching last August, capturing only about 18,000 new prescriptions per month as of May vs. Januvia's roughly 140,000, according to figures from SDI.
Another class of type 2 diabetes drugs could grow in the wake of a negative decision on Avandia, the injectable GLP-1 class. The GLP-1 landscape has evolved with the introduction in April of Novo Nordisk's GLP-1 Victoza. Uptake of Victoza, particularly amongst PCPs, has been strong. That's due primarily to Novo Nordisk's aggressive marketing efforts and the drug's ease of administration, according to a recent note from Collins Stewart analyst Salveen Kochnover. The drug works in a similar fashion to Amylin/Eli Lilly twice-daily injectable Byetta but requires one less needle stick per day. Lilly is also developing a once-weekly GLP-1, named Bydureon.
While today's Avandia review remains a concern, the chances of withdrawal from the US market have lessened, noted Jefferies analyst David Windley. Since the last advisory committee review of Avandia in 2007, two studies have come out that support Avandia's safety profile, he wrote. Most recently, the BARI-2D study data, presented at June's ADA meeting, showed a positive outcome for Avandia in high-risk patients—a statistically significant 28% reduction in the overall incidence of death, heart attacks and stroke.
Then there was the RECORD study. While critics like Dr. Steven Nissen of the Cleveland Clinic have pointed out short-comings in the RECORD study, “we find it unlikely that the panel will disregard its key finding of no increase in CV or all-cause death and a non-significant increase in the rate of heart attacks,” Windley wrote.