FDA to decide on Qnexa obesity drug in July
US regulators will decide in July whether to approve Qnexa, the first obesity drug in more than a decade, extending the initial deadline by three months, the California-based drug-maker VIVUS said.
The extra time is a "standard extension period" offered by the US Food and Drug Administration in order to review additional risk management strategies that were submitted by the company, said a statement issued late Monday.
The new date for a decision is now set for July 17.
An advisory panel to FDA in February urged approval of Qnexa, after warning against its approval in 2010 due to safety concerns.
The panel voted 20-2 that the FDA should allow Qnexa on the market, saying the latest overall benefit-risk assessment supported its approval, but asking for more data on potential risks and how to avoid them.
For instance, some people who took high doses of the drug experienced increased heart rate. When taken by pregnant women it also boosted the risk of having a baby with cleft palate.
"The Qnexa REMS (risk evaluation and mitigation strategy) submission is comprehensive, with materials based on ongoing feedback from the FDA since our advisory committee meeting in February," said Leland Wilson, chief executive officer of VIVUS.
"We look forward to finalizing our REMS with the FDA while we move forward with our commercialization plans."
Qnexa combines two existing drugs, the appetite suppressant phentermine and topiramate, an anti-convulsant that can be used in conjunction with other drugs for weight loss.
Some doctors already prescribe the combination as an off-label use for helping patients manage their weight.
Studies have shown dieters could lose up to 10% of their weight when taking the drug, along with regular exercise and following a healthy diet.
The FDA does not have to follow the advice of the advisory panel, though it usually does.
(c) 2012 AFP
- FDA rejects new obesity drug Qnexa Oct 30, 2010 | not rated yet | 0
- FDA panel backs previously rejected obesity pill Feb 22, 2012 | not rated yet | 0
- Vivus weight loss drug faces FDA panel this week Jul 13, 2010 | not rated yet | 0
- FDA rejects highly-anticipated diet drug Qnexa Oct 29, 2010 | not rated yet | 0
- Experimental drug achieves unprecedented weight loss Apr 11, 2011 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013 From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013 As an experiment, for the past few months I've been consuming at least one portion of Jell-O or unflavored Knox gelatin per day. I'm 64, in very...
Alcohol and acetaminophen
May 13, 2013 Edit: sorry for the typo in the title , can't edit I looked around on google quite a bit and it's very hard to find precise information on the...
Marie Curie's leukemia
May 13, 2013 Does anyone know what might be the cause of Marie Curie's cancer
- More from Physics Forums - Medical Sciences
More news stories
(AP)—Former Navy Secretary Richard J. Danzig, who has served as a bio-warfare adviser to the president, the Pentagon, and the Department of Homeland Security, urged the government to stockpile an anti-anthrax drug while ...
Medications 4 hours ago | 5 / 5 (1) | 0
Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.
Medications May 17, 2013 | not rated yet | 0
Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial with their ...
Medications May 17, 2013 | 5 / 5 (1) | 0
(Medical Xpress)—An aspirin a day may not always keep heart disease away, say two University of Florida cardiologists. But a new algorithm they have developed outlines factors physicians should weigh as ...
Medications May 16, 2013 | 3.5 / 5 (2) | 0 |
(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...
Medications May 15, 2013 | not rated yet | 0
In a new study described in the journal Oncogene, researchers reveal how a key player in cell growth, immunity and the inflammatory response can be transformed into a primary contributor to tumor growth.
1 minute ago | not rated yet | 0 |
The number of young people diagnosed with type 2 diabetes has seen the sharpest rise over the last twenty years compared to a background of a general increase across the board, new University research has ...
1 hour ago | not rated yet | 0
Patients with inflammatory bowel disease (IBD) are at higher risk of melanoma, a form of skin cancer, report researchers at Mayo Clinic. Researchers found that IBD is associated with a 37 percent greater risk for the disease. ...
2 minutes ago | not rated yet | 0
In ICU patients who have septic shock, the anatomic source of infection has a strong effect on the chances of survival, according to a new study from researchers in Canada.
18 seconds ago | not rated yet | 0
(Medical Xpress)—Scientists at King's College London have discovered that Vitamin D has the potential to significantly reduce the symptoms of asthma. The study, led by Professor Catherine Hawrylowicz from ...
1 hour ago | not rated yet | 0 |
(Medical Xpress)—Flinders University researchers are breaking new ground in a decade-long journey to pinpoint the function of two closely related proteins.
1 hour ago | not rated yet | 0 |