What is Belviq?
The Food and Drug Administration (FDA) has approved Arena Pharmaceutical’s anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade. The new drug, developed by Arena Pharmaceuticals of San Diego, has been known as lorcaserin and will be sold under the name Belviq by Eisai Inc., the American branch of the Japanese pharmaceutical company.
The FDA cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.
The drug is approved for adults with a body mass index (BMI) of 30 or over – which indicates obesity – or with a BMI of 27 or greater (overweight) who have at least one weight-related health problem such as high blood pressure, Type 2 diabetes or high cholesterol. It is manufactured by Switzerland-based Arena Pharmaceuticals.
In clinical trials people who took Belviq were twice as likely to lose 5 percent or more of their weight than people who took a placebo. The drug was also linked to improvements in blood pressure, cholesterol and blood sugar levels.
“It’s about time that they approved a new drug,” said Dr. Judith Stern, a professor of nutrition at the University of California at Davis. “Obesity drugs should be on the fast track.”
“For the half of America that seriously needs some help in reducing energy intake, this has some promise,” said Dr. Barry Popkin, a professor of nutrition at the University of North Carolina at Chapel Hill. Other experts have expressed more caution.
However, Belviq won’t immediately be available for sale. The drug has to go through a four-to-six month process at the Drug Enforcement Administration for a scheduling classification used for drugs that have a likelihood or potential of being abused. Once that process is over, Eisai will announce pricing and when the drug will be available.
What is Belviq?
Belviq is a prescription medicine that may help some obese adults or overweight adults who also have weight related medical problems lose weight and keep the weight off.
Belviq should be used with a reduced calorie diet and increased physical activity.
In approving Belviq (formerly known as lorcaserin), the U.S. Food and Drug Administration followed the recommendation of an outside panel of experts who voted 18-4 with one abstention last month to support the weight-loss drug while still voicing concerns about lackluster efficacy and lingering safety questions.
FDA is expected to make its next approval decision for a weight-loss drug on July 17 when it weighs in on Vivus Qnexa. Orexigen Therapeutics will seek approval for its weight-loss drug Contrave pending positive results from an ongoing heart-safety study.
Arena said it was not clear yet when the drug would be available to patients and what it would cost. Because the F.D.A. deemed that there was some potential for the drug to be abused, the Drug Enforcement Administration must now decide what controls to place on prescribers, a process that Arena said could take four to six months.
What are the ingredients in Belviq?
Active Ingredient: lorcaserin hydrochloride
Inactive Ingredients: silicified microcrystalline cellulose; hydroxypropyl cellulose NF; croscarmellose sodium NF; colloidal silicon dioxide NF; polyvinyl alcohol USP; polyethylene glycol NF; titanium dioxide USP; talc USP; FD&C Blue #2 aluminum lake; and magnesium stearate NF.
What are Belviq’s side effects and risk.
The most common side effects of Belviq include:
- dry mouth
- low blood sugar (hypoglycemia) in patients with diabetes
- back pain
It is not known if Belviq is safe and effective when taken with other prescription, over-the- counter, or herbal weight loss products.
It is not known if Belviq changes your risk of heart problems or stroke or of death due to heart problems or stroke.
It is not known if Belviq is safe when taken with some other medicines that treat depression, migraines, mental problems, or the common cold (serotonergic or antidopaminergic agents).
It is not known if Belviq is safe and effective in children under 18 years old.
Do not take Belviq if you are pregnant or planning to become pregnant. Belviq may harm your unborn baby.
Before you take Belviq, tell your doctor if you:
- have or have had heart problems including:
- congestive heart failure
- heart valve problems
- slow heart beat or heart block
- have diabetes
- have a condition such as sickle cell anemia, multiple myeloma, or leukemia
- have a deformed penis, Peyronie’s disease, or ever had an erection that lasted more than 4 hours
- have kidney problems
- have liver problems
- are pregnant or plan to become pregnant.
- are breast feeding or plan to breastfeed. It is not known if Belviq passes into your breastmilk. You and your doctor should decide if you will take Belviq or breastfeed. You should not do both.
The main safety concern is that Belviq works somewhat like fenfluramine, a drug that was part of the popular fen-phen combination but was withdrawn from the market in 1997 because it damaged heart valves. The F.D.A. said Wednesday that it was satisfied that Belviq was unlikely to cause such problems.
Who Makes Belviq
Arena Pharmaceuticals, Inc. is a biopharmaceutical company located in San Diego, California. The company is developing oral medications that target G-protein-coupled receptors. On June 27, 2012, the FDA approved lorcaserin, which will be sold under the brand name Belviq. Lorcaserin is approved for use in adults with a body mass index (BMI) of 30 or greater, which is considered obese, or adults with a BMI of 27 or greater and who have at least one weight-related health condition, such as high blood pressure, type 2 diabetes, or high cholesterol. Arena has other experimental drugs in their pipeline that have not yet been approved by the U.S. Food and Drug Administration, namely (stand January 2009):
Arena is a biopharmaceutical company focused on discovering, developing and commercializing oral drugs that target G protein-coupled receptors, or GPCRs, an important class of validated drug targets, in four major therapeutic areas: cardiovascular, central nervous system, inflammatory and metabolic diseases.
Arena will market and distribute Belviq with Japanese drug maker Eisai, which has exclusive marketing and distribution rights in the United States and most of the rest of North and South America.
6 post marketing studies will be required, including a test of long term cardiovascular safety. Arena will be required to conduct a long-term cardiovascular-outcomes study to access the risks of heart attacks and strokes, in addition to five other post-marketing studies, the FDA said.
Shares of Arena, which had been halted pending the announcement, surged 29%, or $2.54, to $11.39 at 4 p.m. on the Nasdaq Stock Market following the FDA’s decision. The drug would be the first commercial product for the San Diego company, which was founded in 1997 and has been unprofitable.
Other FDA weight loss drugs
The last anti-obesity drug approved in the United States was Xenical (Orlistat) by Roche in 1999.
Sold over the counter as Alli by GlaxoSmithKline, it works by preventing the body from absorbing fat, though its tendency to cause gastrointestinal side effects such as oily, loose stools have curbed its popularity among patients.
Shares of Vivus Inc. climbed Wednesday after regulators approved a rival obesity drug, raising hopes that Vivus’ drug Qnexa will be cleared in July.