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Orexigen obesity pill wins U.S. approval

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Orexigen obesity pill wins U.S. approval 2 years after rivals

WASHINGTON — Orexigen Therapeutics won U.S. approval for its obesity drug, making Contrave the third weight- loss pill to hit the market in the last two years.

The Food and Drug Administration said it cleared the pill, designed to reduce appetite and control cravings, for chronic weight management to be used with a lower-calorie diet and exercise. The drug will compete with Belviq from Arena Pharmaceuticals and Eisai and Vivus' Qsymia. Osaka, Japan-based Takeda Pharmaceutical, Asia's largest drugmaker, will market Contrave, also known as NB32, in the U.S.

Almost 79 million American adults are obese, a condition that carried $147 billion in medical costs in 2008, according to the Centers for Disease Control and Prevention. U.S. sales of Contrave for obesity may total $634 million in 2020, Matthew Andrews, an analyst with Wells Fargo & Co., said in a report.

"Obesity continues to be a major public health concern" Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in FDA's Center for Drug Evaluation and Research, said Wednesday in a statement. "Contrave provides another treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related health condition."

The agency approved the drug Wednesday for those who are obese or overweight based on their body mass index and have at least one related health issue such as Type 2 diabetes or hypertension.

Government programs such as Medicare and Medicaid don't pay for the weight-loss drugs and about 50 percent of people with private insurance receive coverage for diet pills, Charles Duncan, an analyst with Piper Jaffray, said in a telephone interview. Many insurers place the drugs in the third tier of medicines they'll cover, meaning patients pay much of the bill on their own. The addition of La Jolla, California-based Orexigen's medicine may lead coverage to expand, Duncan said.

Belviq is covered for more than 60 percent of those with private insurance and Eisai wants to reach 70 percent coverage by the end of March 2015, Craig Audet, senior vice president of operations and head of global regulatory affairs at San Diego- based Arena, said in an e-mail.

"The launch of new medicines will contribute to the overall development of what has been an under-developed market," Audet said.

Eisai began a national television advertising campaign for Belviq in mid-April and in the second quarter this year filled prescriptions totaled more than 110,000, a 43 percent increase over the previous quarter, he said.

Belviq may generate $808 million in U.S. obesity sales in 2020, Andrews said. Eisai reported $25 million in sales for the drug in the year ending March 31.

Novo Nordisk is also working on an obesity drug called Saxenda, which the Bagsvaerd, Denmark-based company sells in lower doses as Victoza to help adults with Type 2 diabetes control their glucose. A panel of FDA advisers are scheduled to deliberate Thursday whether the agency should approve Saxenda.

Orexigen's Contrave combines bupropion, also used in antidepressants, to help curb appetite, and naltrexone, a treatment to combat alcoholism and opioid dependence, which the company said increases drug tolerability.

Patients using the drug should be evaluated after 12 weeks to determine if the treatment is working, the FDA said in its statement. If a patient hasn't lost at least 5 percent of baseline body weight at that time, Contrave should be discontinued because it isn't likely to help the patient achieve and sustain meaningful weight loss, the agency said.

Orexigen also is pursuing the medicine as a diabetes treatment, which could raises sales in 2020 to $1.2 billion, Andrews said, based on a 65 percent chance it's cleared for diabetes use.

The FDA had previously rejected Belviq, Qsymia and Contrave on safety concerns, particularly whether the treatments carried heart risks. Qsymia and Belviq are being studied post-approval to determine their effect on the heart.

Orexigen presented an interim analysis of a cardiovascular study the FDA asked for in 2011 to show the drug didn't present excess risk. That study is expected to be complete in 2016 or 2017 and "could provide a marketing advantage with prescribers from a safety perspective compared to Qsymia and Belviq," Andrews said.

None of the three weight-loss pills is on the market in Europe. Orexigen's drug is currently positioned to become the first for sale there in 2015.

The agency said Contrave carries a warning about the increased risk of suicidal thoughts connected to bupropion, the antidepressant, and can causes seizures. The drug also carries a risk that it will raise blood pressure and isn't authorized for patients with uncontrolled high blood pressure, the FDA said.

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Takeda And Orexigen Announce FDA Approval Of Contrave® (naltrexone HCI And Bupropion HCI) Extended-release Tablets For Chronic Weight Management

DEERFIELD, Ill., and LA JOLLA, Calif., Sept. 11, 2014 /PRNewswire/ -- Takeda Pharmaceuticals U.S.A., Inc. and Orexigen® Therapeutics, Inc. (Nasdaq: OREX) jointly announced today that the U.S. Food and Drug Administration (FDA) has approved Contrave® (naltrexone HCI and bupropion HCI) extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m ² or greater (obese), or 27 kg/m ² or greater (overweight) in the presence of at least one weight-related comorbid condition.

"Some individuals seeking to manage their weight may require a treatment plan that includes more than lifestyle modification with diet and exercise," said Dr. Ken Fujioka, director, Center for Weight Management, Division of Diabetes and Endocrinology at Scripps Clinic. "Clinical trial data for Contrave demonstrates that this new treatment, when used as an adjunct to a reduced-calorie diet and increased physical activity, is a therapeutic option for some adults who are either overweight with a comorbidity, or obese. In my clinic, I often treat patients who fit these criteria, and now, with the approval of Contrave, I am excited to have a new treatment option to consider for my patients."

Contrave is an important addition to Takeda's portfolio of cardiometabolic products. Takeda is committed to providing patients with obesity with treatment options that help address their needs, and the company is planning to commercially launch Contrave in the fall of 2014.

The effect of Contrave on cardiovascular morbidity and mortality has not been established. In addition, the safety and effectiveness of Contrave in combination with other medications intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.

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