FDA approves first weight-loss treatment in over a decade

FDA has approved lorcaserin (Belviq, Arena Pharmaceuticals and Eisai) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). It is the first prescription weight-loss treatment approved by FDA in 13 years.

The indication includes the following limitations of use: The safety and efficacy of coadministration of lorcaserin with other products intended for weight loss and the effect of lorcaserin on cardiovascular morbidity and mortality have not been established.

Three double-blind, randomized, placebo-controlled trials demonstrated that lorcaserin along with diet and exercise was more effective than diet and exercise alone at helping patients lose 5% or more of their body weight after 1 year and managing the weight loss for up to 2 years.

"Many aspects of lorcaserin hydrochloride remain a mystery, as it pertains to how the general population will use the new agent and how will best fit into patients' complex medication regimens,” said Formulary advisor David G. Fuentes, PharmD, BCPP, CGP, associate professor, clinical and administrative sciences, Roosevelt University, College of Pharmacy, Shaumburg, Ill. “Many drug-drug interactions in patients with common co-occurring conditions have been proactively identified and the healthcare community is hopeful that this new agent will be beneficial in the overweight populations with common cardiac and metabolic diseases. Foreseeable challenges include the impact this novel agent may have on social attitudes regarding weight loss.”

Prescribers will need to reinforce that this agent must be teamed with exercise and a reduced calorie diet, Dr. Fuentes said. “Finally, based on the amassed knowledge about the pitfalls and dangers of past and present weight-loss medications . . . potential side effects should make prescribers and patients deliberate carefully about whether or not to initiate or use this agent."

In clinical trials, the most common adverse reactions for patients without diabetes treated with Belviq were headache, dizziness, fatigue, nausea, dry mouth, and constipation. In patients with diabetes, the most common adverse reactions were hypoglycemia, headache, back pain, cough, and fatigue.

The drug-drug interactions under the important safety information for lorcaserin include certain medications for depression, migraine, the common cold, as well as mood, anxiety, psychotic or thought disorders. Because of possible serious or life-threatening side effects due to drug-drug interactions with lorcaserin, patients should let their healthcare providers know if they are taking any of the following medications: triptans, tricyclics, lithium, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or antipsychotics, linezolid, tramadol, dextromethorphan, tryptophan, or St. John’s Wort.

FDA has recommended that lorcaserin be classified by the US Drug Enforcement Administration (DEA) as a scheduled drug. The DEA will review FDA's recommendation and determine the final scheduling designation. Once the DEA has provided the final scheduling designation, Eisai will announce when lorcaserin will be available to patients and physicians in the United States.

“There appears to be considerable effort to build excitement about this new medication,” Brenna Harrington, healthcare industry public relations executive, told Formulary, the sister publication of Drug Topics. “But, many physicians have not even had a chance to review or study clinical data-they are finding out about this medication at the same time-or in some cases after-their patients. Many physicians today are becoming more comfortable with discussing the value of exercise and weight loss with their patients. The new drug may help them to renew conversations with patients about weight loss. But many physicians feel they have been burned before by weight loss medications and will take a wait-and-see attitude. They want to study the data and see what happens in the real world, how long weight is kept off, possible interactions, etc. The hype is there-but the jury is still out in terms of widespread adoption.”

Arena will manufacture and supply the finished commercial product from its facility in Switzerland, and Eisai will market and distribute lorcaserin in the United States.

As part of the approval of lorcaserin, the companies committed to conduct post-marketing studies to assess the safety and efficacy of lorcaserin for weight management in obese pediatric patients, as well as to evaluate the effect of long-term treatment with lorcaserin on the incidence of major adverse cardiovascular events in overweight and obese subjects with cardiovascular disease or multiple cardiovascular risk factors. The cardiovascular outcomes trial will include echocardiographic assessments.