Arena Pharmaceuticals is getting ready to make another run for U.S. regulatory approval of its obesity drug, and now it has some clinical trial data that the FDA has said it wants to see.
The San Diego-based biotech company (NASDAQ: [[ticker:ARNA]]) is announcing today that its experimental weight loss treatment, lorcaserin (Lorqess), reached all three of its main goals in a clinical trial called Bloom-DM, which enrolled 604 overweight or obese patients who also have Type 2 diabetes. The study essentially showed that these patients, who are generally tougher to treat than other overweight and obese patients, had a similar experience to more than 7,000 patients who participated in the last two pivotal trials, Bloom and Blossom. Some details are being released today to investors, while more details are expected to come out later at a medical meeting and peer-reviewed scientific journal.
Today’s data release represents Arena’s hope for redemption after what has been a brutal couple of months. The company’s application to market its treatment was ripped by FDA staff in September over some concern about tumors in rats, and then the agency formally turned down Arena’s application to start selling lorcaserin, saying it offered only “marginal” ability to help people lose weight. The FDA, in its complete response letter to the company, recommended that the company turn in detailed reports on this other study, Bloom-DM, to provide more evidence that the drug helps people who face the doubly whammy of obesity and diabetes. An estimated two-thirds of people in the U.S. are considered overweight or obese, which puts them at risk for a slew of other chronic, and costly, ailments like cardiovascular disease, arthritis, and depression.
So while the potential benefit—and market—for an effective weight loss would be huge, the FDA has also made clear through its actions this fall against both Arena and one of its competitors, Mountain View, CA-based Vivus (NASDAQ: [[ticker:VVUS]]), that any new drug developer must clear an extremely high bar for safety and effectiveness if it wants to start selling a new product to millions of people in need. San Diego-based Orexigen Therapeutics (NASDAQ: [[ticker:OREX]]), the next obesity drug developer in line at the FDA, will either learn from these lessons and advance onto the market, or step into yet another buzz saw when it appears before an FDA advisory panel on December 7.
Arena CEO Jack Lief wasn’t making any predictions about whether the Bloom-DM study will put his company over the top, but he expressed his usual confidence, and how this latest study will help buttress his argument that lorcaserin deserves a spot in the U.S. market.
“Patients with type 2 diabetes have much more difficulty losing weight than other patients. And although we believed they would benefit, you have to demonstrate that. This study has demonstrated they benefit as well,” Lief says.
Arena plans to crunch the numbers on this latest study, and discuss the new evidence with the FDA before the end of the year, Lief says. Arena’s partner, Japan-based Eisai Pharmaceuticals, remains committed to pushing forward with the program, a spokesman said.
OK, for the stat nerds out there who want to want to dig into what we’ve learned here, now you can get your hands dirty.
Patients who entered this study had an average body mass index of 36, Lief says. People with a body mass index of 30 or greater—which translates to 5-foot-10 and 209 pounds—are considered obese, according to the National Heart, Lung, and Blood Institute. They also entered the study with an average score of 8.0 on their hemoglobin A1c counts—an important measurement of blood sugar control. People are generally considered normal at
