FDA staff say Roche drug helped diabetics see

Update-July 26

U.S. advisers back Roche drug for diabetic eye condition

By David Morgan

WASHINGTON | Thu Jul 26, 2012 10:58pm IST

WASHINGTON (Reuters) - A U.S. Food and Drug Administration advisory panel recommended Roche Holding AG's Lucentis eye drug for treatment of diabetic macular edema, a leading cause of vision loss among working-age people.

The FDA advisory committee of outside experts on Thursday recommended both 0.3 milligram and 0.5 milligram doses of the drug after reviewing clinical research showing it clearly helps diabetic patients who suffer from the vision-robbing condition.

However, some panel members expressed concern about evidence linking higher doses of the drug to adverse events including death.

Agency regulators will now consider the panel's recommendations in deciding whether to approve the drug, known generically as ranibizumab, for treatment of diabetic macular edema, or DME.

Lucentis, which is made by Roche unit Genentech and administered by monthly injection, is already approved for two other eye ailments.

Shares in Roche closed slightly higher at 168 Swiss francs before the panel reached its recommendations.

There are currently no FDA-approved drugs for DME. The condition is currently treated by laser surgery to stop blood vessels from leaking. The treatment can slow vision loss, but it rarely leads to vision improvement.

"The committee's recommendation is an important step towards improving the care of Americans with diabetic macular edema. If approved by the FDA, this will be the first major development for treating diabetic macular edema in more than 25 years," Genentech said in a statement.

The leading cause of vision loss among diabetics, DME occurs when leaking blood vessels in the eye cause swelling at the center of the retina. The result is a progressive blurring of images near the center of a patient's field of vision, and sometimes blindness.

About 75,000 new cases of DME are estimated to develop among Americans each year. Genentech says that about 560,000 in total are affected by the disease.

Clinical trials involving more than 750 patients found that people who received both the 0.3 mg and 0.5 mg doses of Lucentis over 24 months witnessed an improvement in their ability to read eye charts.

Nearly 40 percent of patients on the lower dose and 50 percent on the higher dose saw improvements.

The research also showed both doses to be generally safe. But there were slightly more deaths at the higher dose -- 11 people who received the 0.5 mg dose died during the trials, compared with seven who received the 0.3 mg dose and three who were given a placebo.

Lucentis is already approved to treat wet age-related macular degeneration -- the leading cause of blindness among the elderly. It is also approved for macular edema following retinal vein occlusion (RVO), a swelling or thickening of the part of the retina responsible for central vision.

If approved for DME, Lucentis will likely compete with a highly promising drug being tested by Regeneron Pharmaceuticals Inc and Roche's own cancer drug Avastin, which works in a similar manner as Lucentis.

Shares in Regeneron were up 3.8 percent at $133.76 in afternoon trading on Nasdaq following the advisory panel's decision.

Avastin, which is not approved for eye disease, costs a fraction of the Lucentis price when cut into the small doses needed for eye injection. It has been used extensively off-label in place of Lucentis, hurting sales of the eye drug.

A U.S. government study last year found the two drugs to be similarly effective for macular degeneration treatment.

Genentech has said Avastin increased the risk of stroke and heart attack in cancer trials and noted that diabetics are already at much higher risk for serious heart problems.

(Additional reporting by Anna Yukhananov; Editing by Gerald E. McCormick, Lisa Von Ahn and Tim Dobbyn)
http://in.reuters.com/article/2012/07/26/us-usa-fda-sight-idINBRE86P12T20120726

FDA staff say Roche drug helped diabetics see

By Anna Yukhananov

WASHINGTON | Tue Jul 24, 2012 12:18pm EDT

WASHINGTON (Reuters) - U.S. drug reviewers on Tuesday said Roche Holding AG's eye drug Lucentis appeared to help diabetic patients with a vision-robbing eye condition, and raised few major issues about the drug's safety.

Staff from the U.S. Food and Drug Administration reviewed Lucentis ahead of an advisory panel of outside experts, which meets on Thursday to vote on whether to recommend approval of an expanded use of the drug, which is administered monthly by injection.
However, the FDA staff asked advisers to consider whether both doses of the drug are equally safe and effective, and should be approved.

Lucentis is already approved for two other eye conditions. Roche is hoping to widen its use to people with diabetic macular edema (DME), the most common cause of moderate vision loss in patients with diabetes. There are currently no FDA-approved drugs for DME, a leading cause of vision loss among people of working age.

DME is currently treated by laser, which stops blood vessel leakage and can slow vision loss but rarely leads to vision improvement.

In clinical trials Lucentis, made by Roche unit Genentech, helped patients see at least 15 extra letters on an eye chart, the primary goal of the study, FDA reviewers said.

People were also generally able to sustain the improvement in vision for at least 24 months -- although those who took the 0.5 mg dose lost a bit of vision after the 18th month.

Both doses were generally safe, although there were slightly more deaths at the higher dose -- 11 people who received the 0.5 mg dose died during the clinical trials, compared with seven taking the 0.3 mg dose and three receiving a placebo, or sham injection. Each group contained 250 patients.
The FDA will ask advisers to recommend whether both doses of the drug should be approved for use against DME.

DME is a swelling of the retina that occurs in diabetics who suffer from retinopathy -- the most common diabetic eye disease that involves damaged blood vessels leaking fluid into the retina. It causes blurred vision and severe vision loss.

About 75,000 new cases of DME are estimated to develop among Americans each year -- and Genentech said about 560,000 Americans in total are affected by the disease.
If approved for DME Lucentis will likely compete with a highly promising drug being tested by Regeneron Pharmaceuticals Inc and Roche's own cancer drug Avastin, which works in a similar manner as Lucentis.

Roche shares were down slightly at 167.2 Swiss francs. Shares of Regeneron gained $1.00 to $123.50 in mid-day trading on Nasdaq, where they outperformed the wider Arca Pharmaceuticals Index.
Avastin, which is not approved for eye disease, costs a fraction of the Lucentis price when cut into the small doses needed for eye injection. It has been used extensively off-label in place of Lucentis, hurting sales of the eye drug.

A U.S. government study last year found the two drugs to be similarly effective for macular degeneration treatment.

Genentech has said Avastin increased the risk of stroke and heart attack in cancer trials and noted that diabetics are already at much higher risk for serious heart problems.

Lucentis is already approved to treat wet age-related macular degeneration -- the leading cause of blindness among the elderly. It is also approved for macular edema following retinal vein occlusion (RVO), a swelling or thickening of the part of the retina responsible for central vision.

(Reporting by Anna Yukhananov; Editing by Sofina Mirza-Reid and Maureen Bavdek)
http://www.reuters.com/article/2012/07/24/us-fda-roche-idUSBRE86N0TS20120724