Orexigen Diet Pill Gets FDA Panel Backing

Orexigen Diet Pill Gets FDA Panel Backing
by Bertha Coombs

Come the new year, when millions of Americans resolve the lose weight, the Food and Drug Administration will set out to decide whether to give them and their doctors a new drug to help in the battle against obesity.

“Health care providers have to have something” to help obese patients. “So, I have a greater threshold for accepting a tolerable risk.”

Drug maker Orexigen Therapeutics on Tuesday cleared a major hurdle in its effort to bring its weight loss drug Contrave to market. A Food and Drug advisory panel recommended approval of the drug, voting 13 to 7 that the diet pill’s benefits outweigh the risks.

“I am struck by the epidemic of obesity,” advisory panel member Allison Goldfine MD explained, discussing her vote to recommend approval despite concerns about trial data showing the pill caused elevated blood pressure in some patients.

“Health care providers have to have something” to help obese patients, Dr. Goldfine explained following the vote. “So, I have a greater threshold for accepting a tolerable risk.”

Diet Drug Risks: A History of Risks

Two-thirds of Americans are overweight ore obese. Contrave marks the first new obesity drug FDA advisors have recommended in over 10 years, since the controversial diet drug Fen-phen was pulled off the market in the late 1990s over serious heart disease side effects.

As part of its recommendation, the advisors voted that Orexigen must conduct a larger post-approval clinical trial to investigate the heart risks posed by Contrave. But some committee members voiced concerns approving the drug with the long-term impact of side effects still not fully understood, with more than one saying the FDA risks eroding public confidence if it once again has to pull a diet drug off the market.

“The biggest adverse effect is another drug failure,” said advisory panel member Dr. Jules Hirsch, professor emeritus of Rockefeller University, who voted against approval. “This is the very likely outcome of this.”

FDA Panel Vote Lifts Orexigen’s Rivals

Contrave is the third obesity drug to come up for regulatory consideration this year.

The FDA panel’s positive recommendation sent of Orexigen’s weight loss drug rivals Vivus [VVUS 8.83 1.03 (+13.21%) ] and Arena Pharmaceuticals [ARNA 1.59 0.18 (+12.77%) ] higher.

Shares of Orexigen [OREX 9.69 4.93 (+103.57%) ], halted ahead of Tuesday’s meeting, did not resume trading after the vote.

In October, FDA advisors rejected Arena’s drug lorcaserin to treat patients with diabetes, asking for more data on studies that showed the drug may have caused tumors in rats.

The advisory panel also rejected Vivus’ Qnexa, over data that showed a potential for the drug to cause serious birth defects.

“Right now both those companies are in discussion with the FDA about what to do next,” says Needham biotech analyst Alan Carr.

Carr believes all three drugs could ultimately win approval, if the risks are address. He says one thing working Vivus’ favor, is studies show Qnexa produced greater weight loss results than its rivals.

The demand is so great, a new obesity drug could easily reach a $1 billion in annual sales, Carr says. That’s part of the reason he believes the drug makers and regulators will have to spell out strict rules for prescribing these drugs.

“That’s what I think the FDA and these companies have to be very serious about—that these are used properly.”

The FDA is not bound by the advisory committee’s vote, but often follows its recommendations. The agency is expected to make a decision on Contrave by January 31st.