FDA approves Regeneron's eye injection Eylea

By MARLEY SEAMAN , AP Health Writer

(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 , 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 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 to treat 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.

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dogbert
5 / 5 (1) Nov 19, 2011
Regeneron said it will launch Eylea next week. Each dose will cost $1,850, while Lucentis costs $2,000.


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.


Why do we need new drugs which cost 40 times as much as a $50 drug if the $50 drug works as well?
Blakut
not rated yet Nov 19, 2011
Well, the second one is a cancer drug. This may mean it can have potentially unpleasant side effects.
dogbert
5 / 5 (1) Nov 19, 2011
Ranibizumab (Lucentis) and bevacizumab (Avastin)are both derived from the same monoclonal antibody and are both anti-angiogenic (suppresses blood vessel generation). Suppression of blood vessel growth is one method of attacking cancer growth.

Eylea is also anti-angiogneic.

Suppressing blood vessel growth can be expected to have considerable side effects.
Ethelred
5 / 5 (1) Nov 19, 2011
Those are nasty drugs and all have nasty side effects.

Avastin was denied approval for breast cancer because it did squat and has nasty side effects.

Macular degeneration is pretty nasty too so if the drugs actually work for it and there is no alternative then, as long as people are FULLY informed, it is reasonable to use them.

I have a sneaky suspicion the big cost is that actual process of the injection. It is likely that is going into the eye. Which is going to cost a lot more than that 50 bucks for the avastin.

Ethelred
dogbert
not rated yet Nov 19, 2011
I have a sneaky suspicion the big cost is that actual process of the injection. It is likely that is going into the eye. Which is going to cost a lot more than that 50 bucks for the avastin.


Of course, the injection by a physician is going to add to the cost of the procedure. But whatever that cost, adding $50 for the drug versus $2000 for the drug is a significant difference.