FDA approves Regeneron's eye injection Eylea
(AP) -- Regulators on Friday approved Regeneron Pharmaceuticals Inc.'s drug Eylea, an injection designed to treat a common cause of blindness in older people.
Eylea is intended to treat neovascular or "wet" age-related macular degeneration. More than 200,000 cases are diagnosed in the U.S. every year. The standard treatment for the condition is Roche's Lucentis, which was approved in 2006 and posts $1.5 billion in annual sales.
Analysts have high expectations for Eylea because clinical trial data showed it could be administered every other month, although the Food and Drug Administration recommends monthly injections for the first three months and then bimonthly.
Lucentis is approved to be used once per month, although Roche says the drug is often used less frequently.
Regeneron said it will launch Eylea next week. Each dose will cost $1,850, while Lucentis costs $2,000. The company said health insurers and programs like Medicare will save money because patients won't have to visit their doctor as often for injections and checkups. It said those visits cost $250 to $300 each.
Earlier this year, clinical trial data showed Roche's cancer drug Avastin, which is chemically similar to Lucentis, was as effective as Lucentis. A specialty-formulated injection of Avastin costs $50.
Separately, on Friday the FDA withdrew its approval to market Avastin to treat breast cancer because of concerns that the drug's side effects were too great and that it didn't help enough, although it will remain on the market for certain colon, lung, kidney and brain cancers
The most common side effects of Eylea included bleeding of the conjunctiva, eye pain, cataracts, detachment of the retina from the vitreous humor, and greater pressure within the eye. In a few patients, strokes, nonfatal heart attacks, and vascular death, including deaths of unknown cause, occurred. Those side effects occurred in about 1.8 percent of patients combined.
An FDA advisory panel unanimously recommended approval for Eylea in June, but in August, the FDA extended its review of the drug by three months to check additional data.
If the drug is approved in other markets, Bayer HealthCare will market Eylea and the companies will split the profits.
Shares of Regeneron fell $1.32, or 2.6 percent, to close at $49.81before the company announced the FDA approval. The stock picked up 54 cents to $50.35 in aftermarket trading.
©2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
- FDA panel unanimously backs Regeneron eye drug Jun 17, 2011 | not rated yet | 0
- Cheaper eye drug proves as good as pricier one Apr 28, 2011 | not rated yet | 0
- Researchers find no difference in drugs for macular degeneration Oct 01, 2010 | not rated yet | 0
- FDA says breast cancer drug did not extend lives Jul 16, 2010 | not rated yet | 0
- Study finds Avastin and Lucentis are equally effective in treating AMD Apr 28, 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
A new report suggests that improved health care and significant reductions in drug costs might be attained by breaking up the age-old relationship between physicians and drug company representatives who promote the newest, ...
Medications 5 hours ago | not rated yet | 0
Federal health regulators say an experimental insomnia drug from Merck can help patients fall asleep, but it also carries worrisome side effects, including daytime drowsiness and suicidal thinking.
Medications 7 hours ago | not rated yet | 0
(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 13 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) | 1
(Medical Xpress)—A research team, led by Jeremy Barr, a biology post-doctoral fellow, unveils a new immune system that protects humans and animals from infection.
4 minutes ago | not rated yet | 0 |
University of Minnesota Medical School researchers from the Masonic Cancer Center, University of Minnesota, in partnership with the University's Brain Tumor Program, have developed a new mouse model of malignant peripheral ...
49 minutes ago | not rated yet | 0 |
Turns out, that old "practice makes perfect" adage may be overblown. New research led by Michigan State University's Zach Hambrick finds that a copious amount of practice is not enough to explain why people ...
59 minutes ago | 5 / 5 (2) | 0 |
Older prostate cancer patients with other underlying health conditions should think twice before committing to surgery or radiation therapy for their cancer, according to a multicenter study led by researchers in the UCLA ...
46 minutes ago | not rated yet | 0 |
A new diagnostic test for a worm infection that can lead to severe enlargement and deformities of the legs and genitals is far more sensitive than the currently used test, according to results of a field ...
47 minutes ago | not rated yet | 0 |
Study shows that women who smoke during pregnancy increase the risk of both obesity and gestational diabetes in their da
Women who smoke during pregnancy increase the risk of both obesity and gestational diabetes, in their daughters, concludes research published in Diabetologia, the journal of the European Association for the Study of Diabet ...
31 minutes ago | not rated yet | 0