In U.S., more obesity drugs vying to stand out

Drugmakers aren’t giving up on a pharmaceutical remedy for the United States’ obesity woes even as sales for much-anticipated weight-loss pills have fallen short of estimates.

The Food and Drug Administration was scheduled to decide by Thursday whether to approve Orexigen Therapeutics’s obesity drug, the same day the agency is convening its advisors to discuss an injection to combat growing waistlines from Novo Nordisk.

These potential therapies would follow Belviq from Arena Pharmaceuticals and Eisai Company approved in June 2012, the first weight-loss pill cleared in 13 years, which was followed three weeks later by Vivus’ Qsymia. While initial sales didn’t meet estimates as high out-of-pocket costs deterred patients, the addition of new treatments may finally spur consumer acceptance for the obesity pills, Charles Duncan, an analyst with Piper Jaffray, said.

“Being third is absolutely a good thing,” Duncan said in a telephone interview, referring to Orexigen. “Being first was not good because there was virtually zero reimbursement for drug-based therapy before. There needed to be a kind of change in the attention toward obesity and the usefulness of a drug for that.”

About 50 percent of people with private insurance re- ceive at least some coverage for diet pills, Duncan said. Many insurers place Qsymia and Belviq in the third tier of drugs they’ll cover, which is the tier where patients pay the largest chunk of the bill out of their own pockets.

Government programs such as Medicare and Medicaid don’t pay for the drugs, Duncan said. He anticipates coverage will expand if La Jolla, Calif.-based Orexigen’s weight-loss drug, known as NB32, is approved.

The FDA is expected to decide whether to clear Bagsvaerd, Denmark-based Novo Nordisk’s diet shot liraglutide for sale by the end of October. The injection is sold as Victoza to help adults with Type 2 diabetes control their glucose.

Novo Nordisk has proposed selling the injection to adults who are considered obese or are overweight and have another disease as a result of their condition, such as diabetes. Safety issues that may be raised by FDA staff in documents to be released this week include cancer concerns.

The FDA said in March 2013 it is reviewing a possible link between diabetes drugs called incretin mimetics, including Victoza, and the risk of developing an inflammation of the pancreas tied to cancer. Victoza also bears a warning that studies on rodents found thyroid tumors and the relevance of that risk in humans hasn’t been established.