Entries in Approval (10)


FDA Approves Johnson & Johnson Drug for Tuberculosis

Cristina Arias/Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration gave its stamp of approval to Johnson & Johnson's drug, called Sirturo, that will treat a drug-resistant form of tuberculosis.

This form of tuberculosis (MDR-TB) is a bacterial infection, resistant to multiple drugs, and can be fatal. It affects as many as 630,000 people globally, although it is not as common in the U.S., according to Dr. Paul Stoffels, chief scientific officer and worldwide chairman at Johnson & Johnson.  

Though less than 100 cases of MDR-TB have been reported in the U.S., Stoffels says the FDA's approval of Sirturo, also called bedaquiline, "is a significant step" in fighting the global disease.  In fact, the company does not expect the drug to be a large driver of revenue.  Johnson & Johnson spokesperson Pamela Van Houten said that "commercial opportunity is very limited," according to a Wall Street Journal report.

"This is part of our commitment to advance innovative medicines that help address serious public-health issues," Van Houten said.

The Wall Street Journal reports that Johnson & Johnson expects to begin selling Sirturo in the second quarter of 2013. The company will hold off on announcing the drug's sales price until that time.

Copyright 2012 ABC News Radio


FDA Approves Weight Loss Drug Qnexa

Lauren Nicole /Digital Vision(WASHINGTON) -- The U.S. Food and Drug Administration (FDA) has approved the diet drug Qnexa, the agency's latest move to give doctors and their patients more tools to fight excessive weight gain as obesity rates continue to bulge in the U.S. and around the world.

An advisory panel in February had voted 20 to two in support of Qnexa. The FDA's decision Tuesday marks the first time the agency is consenting to a weight-loss drug in more than a decade. Data presented by Vivus, Qnexa's manufacturer, showed that it helped patients lose about 10 percent of their body weight.

The committee's recommendations and Tuesday's approval by the FDA drew both praise and criticism, reflecting concern over the drug's side effects as well as the need to give patients more choices beyond diet, exercise and bariatric surgery.

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"Considering the heavy toll of obesity in our society, this agent has tremendous potential," said Dr. Chip Lavie, medical director of cardiac rehab and prevention at the Ochsner Medical Center in New Orleans.

"I do think it will help a subpopulation lose weight. However, I am concerned that mass marketing of this drug will perpetuate the magic bullet approach to weight loss, which is limiting and does not address the root problem," said Dr. Gerard Mullin, an associate professor at Johns Hopkins School of Medicine.

About one-third of Americans are obese, and many have chronic, expensive medical conditions as a result, such as heart disease, diabetes and arthritis. Until recently, the array of available medical options has been frustratingly sparse for many doctors and their obese patients: diet, exercise and, for those overweight enough to qualify, bariatric surgery.

"I think it's clear from current research that there are problems with weight-regulating mechanisms in the brain that make it difficult for people to lose and maintain weight," said Dr. Louis Aronne, director of the Comprehensive Weight Control Program at New York Presbyterian Hospital. "We need to come to that realization that we're better off treating people who are obese than blaming them."

Qnexa is a combination of two FDA-approved drugs: phentermine, a stimulant related to the amphetamines that suppresses the appetite, and topiramate, a drug used to treat migraines and epilepsy that has weight-loss side effects. Vivus emphasizes that the drug is intended to be used in combination with diet and exercise.

In June, the FDA approved another diet drug, lorcaserin or Belviq. The drug is also an appetite suppressant and intended for patients who are obese and have one additional weight-related health problem, such as high blood pressure, type 2 diabetes or high cholesterol. However, studies of Belviq found that patients lost about four percent of their body weight, compared with the 10 or 12 percent lost by Qnexa patients.

But Qnexa is not without drawbacks. When Qnexa's manufacturer, Vivus, initially submitted the drug for approval in 2010, the FDA voted it down, citing concerns over the potential for dangerous heart problems, birth defects and cognitive effects such as mental fogginess or lack of concentration in patients taking the drug.

The 2012 panel voted to approve the drug only with Vivus' assurances that the company would provide detailed information to physicians about the risks of the drug and how to manage them.

Still, doctors are mixed in their concern over the potential for side effects, particularly in light of the history of diet drugs, such as fen-phen, approved by the FDA, then withdrawn from the market over concerns about heart risks and other dangerous side effects.

"Honestly, I won't be surprised if adverse effects over time result in a reversal of the approval," said Dr. David Katz, director of the Yale Prevention Research Center. "But in the interim, it will help some people lose weight, and many others will try it, dislike it and stop, and gain the weight back."

Evans said she's gained about 20 pounds since she stopped taking Qnexa in 2009. She said the gain is due in part to an injury to her Achilles tendon that has kept her from being as active as she was. But she said she would definitely consider taking it again to help her bring her weight down.

"Just to know that it's available if I need it, that's a real nice little prize," she said.

Copyright 2012 ABC News Radio


Qnexa Ruling Renews Debate About Its Risks and Benefits

FDA/iStockphoto/Thinkstock(WASHINGTON) -- The decision by a federal advisory panel to recommend Qnexa for approval by the U.S. Food and Drug Administration is drawing praise and criticism from obesity and diet experts, reflecting a still-hot debate on the need for additional tools to treat obesity.

The 20-2 decision recommending approval Wednesday came as a surprise to many experts. The FDA has not approved a weight-loss drug in the past 13 years and has withdrawn from the market many drugs due to concerns over heart risks and other side effects.

Qnexa was rejected by the agency in 2010 after a 10-6 vote against approval by the same panel, which included about half of the same members as Wednesday's.

But the panel this week agreed that the health risks of obesity and the benefits of losing weight outweighed the risks posed by the drug.

"The approval of Qnexa is a major step forward for the field of obesity treatment and is the result of advances in our understanding of the health consequences of obesity, and the resistance mechanisms that make it difficult to lose weight," said Dr. Louis Aronne, director of the Comprehensive Weight Control Program at New York Presbyterian Hospital.

Qnexa's rejection in 2010 was largely due to concerns over the potential for heart problems, birth defects and mental effects such as lack of concentration and fogginess for patients taking the drug.

The panel seemed to be moved this time by plans by the drug's manufacturer, Vivus, to minimize those risks through measures like labeling and an additional trial to investigate cardiovascular side effects.

But some experts say the side effects are still a major concern for a drug that will likely be sought by millions of people.

"This is far from a great drug," said Dr. David Katz, director of the Yale Prevention Research Center. "The FDA panel recommended approval of Qnexa only because the ranks of useful weight loss drugs are so thin, and desperate times call for desperate measures. Approval of Qnexa would reflect that...desperation."

One-third of Americans are obese and have chronic, expensive health problems as a result -- diabetes, heart disease and arthritis, to name a few. Patients and doctors are often frustrated by the lack of middle-ground options between traditional recommendations for diet and exercise and the more extreme approach of bariatric surgery.

Patients and doctors aren't the only ones antsy for a solution. The FDA has faced mounting pressures from health care groups and patient advocacy organizations to take obesity more seriously as a condition worthy of pharmacological treatment. In a letter in September, the U.S. Senate Appropriations Committee directed the FDA to file a report by March 30, 2012 on the steps it will take to "support the development of new treatments for obesity."

Critics say the search for an anti-obesity drug is nothing more than a search for a "magic bullet" cure for obesity to eliminate the need for making difficult lifestyle changes.

"The approval of Qnexa feeds into a quick-fix approach to weight management," said Dr. Gerard Mullin, associate professor at Johns Hopkins School of Medicine. "The solution to the overweight-obesity epidemic lies not in another effortless 'quick fix' but in a painful but permanent lifestyle solution."

Qnexa is a combination of two drugs already approved by the FDA: phentermine, a stimulant that suppresses appetite, and topiramate, a drug used to treat migraines and epilepsy that has weight loss as a side effect. Vivus recommends that the drug be prescribed as a part of weight loss plans that include diet and exercise.

Clinical trials so far show that the drug helps people shed 10 percent of their body weight, although patients regained some weight in the second year on the drug. It also seemed to have positive effects on blood sugar and blood pressure.

The FDA will decide whether or not to approve Qnexa by April 17. Although the agency usually follows the recommendations of its panels, the drug's fate is not assured. In 2011, a panel recommended the weight loss drug Contrave for approval, but the FDA declined to follow its advice.

Copyright 2012 ABC News Radio


FDA Panel Recommends Approval of Diet Drug Qnexa

FDA/iStockphoto/Thinkstock(WASHINGTON) -- A U.S. Food and Drug Administration Advisory Committee Wednesday recommended approval of the weight loss drug Qnexa, a treatment many hope will help millions of Americans who struggle with obesity.

In voting 20-2 for approval, the committee said Wednesday that Qnexa’s weight-loss benefits for the chronically obese outweighed the risks of birth defects and cardiovascular problems that have been associated with the drug. An FDA advisory panel recommended against approval in 2010 over concerns about the drug’s side effects, and the FDA rejected it shortly after that. Vivus, the drug’s manufacturer, recently submitted additional research.

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The committee Wednesday recommended that the manufacturer take a number of steps to prevent the drug from causing birth defects like cleft palate, including a possible warning label targeted toward women of childbearing years.

The FDA has considered numerous anti-obesity drugs in the past 20 years, but most have failed to meet the agency’s standards for safety and effectiveness. But so far, data on Qnexa suggests that the drug is the most effective in helping patients shed up to 10 percent of their body weight. Those changes, along with diet and exercise modifications, could go a long way toward alleviating some of the health problems associated with obesity, such as diabetes and high blood pressure.

Critics say the risk of potentially dangerous side effects of Qnexa, which include increased heart rate, heart attacks and arrhythmias, are too great to make the drug available to millions of people, especially because long-term effects of the drug are still largely unknown.

“Public health cannot tolerate another diet drug approved that has not been accepted for cardiovascular risk especially in light of the suggested findings of Qnexa,” said Dr. Sidney Wolfe, director of the health research group at Public Citizen, an advocacy group.

Obesity currently plagues one-third of Americans and has been linked to high blood pressure, diabetes and a range of other chronic, expensive health problems. Doctors and dietitians routinely recommend changes in diet and exercise as the safest and most effective way to shed pounds. But some acknowledge that these strategies just don’t work for a large number of obese patients. Bariatric surgery, though largely successful in producing weight loss, is not a viable option for many people.

Dr. Melina Jampolis, an obesity specialist in San Francisco, said the current options for treating obesity are “frustratingly limited,” and said it would be helpful if patients had additional tools to aid their weight loss.

“I think that combination therapy is essential as there are numerous individual and overlapping mechanisms that make weight loss difficult,” she said. “So the more of them that you can address with medication therapy when necessary, the more effective a regimen will be.”

Copyright 2012 ABC News Radio


Prevnar 13 FDA-Approved for Adults 50 and Older

PRNewsFoto/Amgen/Hemera/Thinkstock(NEW YORK) -- The pneumococcal vaccine Prevnar 13 has been approved by the FDA for use in adults ages 50 and over, Pfizer said Friday.

"Pneumococcal disease, including pneumonia, in adults 50 years and older represents a significant personal and societal health burden in the United States. The FDA approval of Prevnar 13 for these adults offers the potential to contribute to the health of millions of aging Americans,” Ian Read, chairman and chief executive officer of Pfizer Inc. said in a statement Friday.

According to Pfizer, Pneumococcal disease (PD) is growing as a leading public health issue for adults 50 and older in the U.S., where there are "hundreds of thousands of S. pneumoniae infections per year, including more than 440,000 cases of pneumococcal pneumonia, accounting for an estimated 200,000 emergency department visits and 300,000 hospitalizations."

“Clearly, there remains a high incidence of pneumococcal pneumonia in this adult population,” said Emilio Emini, Ph.D., chief scientific officer, Vaccine Research for Pfizer. “Prevnar 13 was licensed for adults 50 years and older by the FDA under an accelerated approval pathway because of its potential to help address this significant disease burden.”

Previously Prevnar's use in the U.S. was limited to the prevention and treatment of ear infections, sepsis and meningitis in children, the Wall Street Journal reports.

Copyright 2011 ABC News Radio


FDA Approves New Drug for Hepatitis C, Incivek

Comstock/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration Monday approved a new drug that researchers say can help clear out the Hepatitis C virus faster.

The FDA approved Incivek after three clinical trials sponsored by the drug's maker, Vertex Pharmaceuticals.  The trials showed that a higher percentage (79 percent) of patients saw improvement with Incivek vs. using the older drugs alone.  The FDA also reported that Incevek appeared to cut treatment time in half, from 48 weeks to 24 weeks.

Incivek's approval comes just after the FDA gave the go-ahead for Victrelis, another drug in the same class.  Now, Dr. Edward Cox, a director at the FDA's Center for Drug Evaluation and Research, says the approval of both drugs offer a "greater chance at a cure" for Hepatitis C patients.

Side effects of both Incivek and Victrelis include anemia, nausea and headaches, according to the FDA.  However, experts have high expectations for the new treatments.

"Both patients and physicians are really excited about the approval of this drug, which represents a huge advance in the treatment of hepatitis C," Dr. Douglas Dieterich of the Mount Sinai School of Medicine in New York City told HealthDay News.  "It is expected to almost double the cure rate of this disease."

Hepatitis C is an infection of the liver that affects more than three million Americans and is responsible for the majority of liver transplants performed in the U.S., according to the U.S. Centers for Disease Control and Prevention.  It can be spread by sharing needles, toothbrushes or razors with an infected individual, or by sexual contact.

Copyright 2011 ABC News Radio


New HIV Treatment Approved by FDA

ABC News Radio(WASHINGTON) -- The U.S. Food and Drug Administration (FDA) has given approval to a new treatment for adults infected with HIV.

The FDA announced the approval of the drug Edurant (rilpivirine) on Friday, which officials say when used in combination with other antiretroviral drugs, can treat HIV-1 infection in patients who have never taken HIV therapy. The FDA says Endurant is to be used as part of a highly active antiretroviral therapy regimen aimed at suppressing HIV levels in the blood.

“FDA’s approval of Edurant provides an additional treatment option for patients who are starting HIV therapy,” said Edward Cox, M.D., M.P.H, director, Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

The approval comes following a trial phase involving over 1,300 adult patients with HIV.

Copyright 2011 ABC News Radio


Cartoid Stent Approved for Wider Use

Pixland(WASHINGTON) -- Officials have approved an expanded indication that will allow a new group of patients who face the risk of stroke, to be treated with the RX Acculink carotid stent.

The U.S. Food and Drug Administration (FDA) announced the approval on Friday, allowing patients with the risk of stroke due to clogged neck arteries to have the stent implemented. This is a follow-up to the 2004 move by the FDA to allow RX Acculink for use with patients who had clogged arteries and were faced with the risk of complications if they underwent surgical treatment that involved scraping out plaque from the neck artery.

The FDA’s latest approval regarding the RX Acculink, extends the indication for use of the stent to all patients with clogged carotid arteries who face the risk of stroke.

“Expanded access to RX Acculink means patients and their health care providers have another option for treating clogged neck arteries,” said Christy Foreman, M.B.E., director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

According to a release from the FDA, with the RX Acculink, a catheter is inserted into the groin and then threaded up to the affected neck artery, following which a stent is placed into the artery to keep it open.

The FDA’s approval comes following a 10-year study that involved 2,502 patients at 119 clinical sites in the United States and Canada.

Copyright 2011 ABC News Radio


Medical Device Recalls Reveal Cracks in Regulatory Procedures, Researchers Say

Photo Courtesy - Getty Images(CLEVELAND) -- The approval process for medical devices has been the topic of growing scrutiny. Monday, a study published in the Archives of Internal Medicine suggests most medical devices recalled for life-threatening or very serious hazards were cleared by the Food and Drug Administration through an expedited review process called 510(k), or were considered so "low risk" they were exempt from review entirely.

"In my view, the regulatory system is failing," said Dr. Steven Nissen, a co-author of the study and chairman of cardiovascular medicine at the Cleveland Clinic.

Nissen and colleagues examined the number of medical device recalls from 2005 to 2009 and determined which regulatory pathway they had taken -- 510(k) or the more rigorous premarket approval process. Of 113 recalls of devices determined by the FDA to cause serious health problems or death, 80 were cleared through 510(k), and eight were exempt from FDA regulation.

"Some 80 percent or so of devices being recalled were actually never fully clinically tested in people," Nissen said.

It's unclear from Nissen's study how many devices approved through the standard PMA pathway have been recalled.

If a device is shown to be substantially similar to one already on the market, the 510(k) pathway allows its makers to bypass the PMA pathway's rigorous preclinical testing and inspections.

For implantable devices, like an artificial hip or an artificial heart valve, a recall means an operation.

"If you want to take back a heart valve you have to sit down with a patient and say, look, we have two very different, bad choices here. We can wait until your device fails, or we can go in and do an operation and put a new device in," Nissen said. "Those are very difficult choices."

Copyright 2011 ABC News Radio


FDA to Improve Premarket Review of Medical Devices

Photo Courtesy - Getty Images(SILVER SPRING, Md.) -- The U.S. Food and Drug Administration announced plans Wednesday to improve the most common path to market for medical devices. The agency revealed its plan consisting of 25 actions to implement during 2011.

Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health (CDRH), hopes these new actions will result in "a smarter medical device program that supports innovation, keeps jobs here at home and brings important, safe and effective technologies to patients quickly."

Key measures of the plan include establishing a new Center Science Council of senior FDA experts who will ensure timely and consistent decision making based on science, new guidance that will increase the efficiency of the premarket review process, and a recommendation of a suitable time for submission of clinical data for premarket review.

Copyright 2011 ABC News Radio

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