FDA Approves New Drug to Fight Advanced Prostate Cancer

Xofigo was fast-tracked for approval and is meant for tumors that have spread to the bones

By EJ Mundell

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

Xofigo is co-marketed in the US by Wayne, N.J.-based Bayer Pharmaceuticals and Algeta US of Cambridge, Mass.

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FDA Approves 'Abuse-Deterrent' Label for New Oxycontin

Latest formulation is tougher to crush and dissolve, making illicit use more difficult

By EJ Mundell

HealthDay Reporter

TUESDAY, April 16 (HealthDay News) -- In an effort to help curb the epidemic of prescription painkiller abuse, the U.S. Food and Drug Administration on Tuesday said it is approving new labeling for a reformulated version of Oxycontin that its maker claims will be harder to abuse.

The agency also noted that the original form of the powerful painkiller has been withdrawn from the market because it is easier to abuse than the newer formulation.

"Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin," the FDA added in a news release issued late Tuesday.

Prescription painkiller abuse continues to be a major problem across the United States. According to a report issued in January by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA), some 22 million Americans -- 2 percent of the population -- have misused prescription painkillers since 2002.

Oxycontin (oxycodone hydrochloride controlled-release) already has Schedule II status as a potentially harmful and restricted-access narcotic, based on an FDA review. In January, an agency advisory panel voted to move other hydrocodone-containing painkillers such as Vicodin and Percocet to the same status.

One other way to rein in rampant abuse of precription narcotics is to develop formulations that are more difficult to break down and abuse.

The original form of Oxycontin, first approved in 1995, "was abused, often following manipulation intended to defeat its extended-release properties," the FDA explained. "Such manipulation causes the drug to be released more rapidly, which increases the risk of serious adverse events, including overdose and death."

The new, "abuse-deterrent" version was approved in 2010 after being developed by maker Purdue Pharma, and the company stopped shipments of the older version of Oxycontin to pharmacies in August of that year.

The new version is "more difficult to crush, break or dissolve," the FDA said, and it forms a thick, sticky gel that resists being used as an injection. It is also more difficult to manipulate the drug so it can be snorted, the agency said.

"The reformulated product also may reduce incidents of therapeutic misuse, such as crushing the product to sprinkle it onto food or to administer it through a gastric tube," the agency noted.

"The development of abuse-deterrent opioid analgesics is a public health priority for the FDA," Dr. Douglas Throckmorton, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, said in the agency's news release. "While both original and reformulated OxyContin are subject to abuse and misuse, the FDA has determined that reformulated OxyContin can be expected to make abuse by injection difficult and expected to reduce abuse by snorting compared to original OxyContin."

The FDA notes that postmarketing studies looking at the abuse potential of the new formulation are ongoing.

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FDA Approves 1st in New Class of Type 2 Diabetes Drugs

Title: FDA Approves 1st in New Class of Type 2 Diabetes Drugs
Category: Health News
Created: 3/29/2013 6:35:00 PM
Last Editorial Review: 4/1/2013 12:00:00 AM

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FDA Approves 1st in New Class of Type 2 Diabetes Drugs

Invokana works by blocking reabsorption of glucose in body

By Robert Preidt

HealthDay Reporter

FRIDAY, March 29 (HealthDay News) -- The first in a new class of type 2 diabetes drugs was approved Friday by the U.S. Food and Drug Administration.

Invokana (canaglifozin) tablets are to be taken, in tandem with a healthy diet and exercise, to improve blood sugar control in adults with type 2 diabetes.

Invokana belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works by blocking the reabsorption of glucose (sugar) by the kidney and increasing glucose excretions in urine, the FDA said in a news release.

"We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health," Dr. Mary Parks, director of the division of metabolism and endocrinology products in the FDA's Center for Drug Evaluation and Research, said in the news release.

About 24 million Americans have type 2 diabetes, and it accounts for more than 90 percent of diabetes cases diagnosed in the United States, the FDA said. If blood sugar levels are not carefully controlled, there is an increased risk for serious complications, including heart disease, blindness, and nerve and kidney damage, the agency added.

The FDA approval is based on the findings of nine clinical trials involving more than 10,000 patients. Patients who took the drug showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting blood sugar levels.

Invokana should not be used by people with type 1 diabetes or people with type 2 diabetes who have increased ketones in their blood or urine (diabetic ketoacidosis), severe kidney disease, kidney failure or who are on dialysis, the FDA said.

The agency told drug maker Janssen Pharmaceuticals that it must conduct five post-approval studies of the drug to determine the risk of problems such as heart disease, cancer, pancreatitis, liver abnormalities and pregnancy complications.

The most common side effects of Invokana are vaginal yeast infections and urinary tract infections. It may also cause dizziness and fainting.

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FDA Approves New Drug to Fight Advanced Prostate Cancer

Xofigo was fast-tracked for approval and is meant for tumors that have spread to the bones

By EJ Mundell

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

Xofigo is co-marketed in the US by Wayne, N.J.-based Bayer Pharmaceuticals and Algeta US of Cambridge, Mass.

View the original article here

FDA Approves 'Bionic Eye' to Help Against Rare Vision Disorder

Title: FDA Approves 'Bionic Eye' to Help Against Rare Vision Disorder
Category: Health News
Created: 2/14/2013 6:36:00 PM
Last Editorial Review: 2/15/2013 12:00:00 AM

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FDA Approves 'Bionic Eye' to Help Against Rare Vision Disorder

By Steven Reinberg

HealthDay Reporter

THURSDAY, Feb. 14 (HealthDay News) -- An implanted, sight-enhancing device some are calling a "bionic eye" is the first to gain approval for use in the United States, officials announced Thursday.

According to the U.S. Food and Drug Administration, the new Argus II Retinal Prosthesis System can help patients with a genetic eye disease called retinitis pigmentosa regain some sense of vision. About 100,000 Americans are believed to be affected by the illness, which causes a gradual deterioration of the eyes' photoreceptor cells.

The new device uses a tiny video camera attached to eyeglasses that transmits images to a sheet of electrode sensors that have been sewn into the patient's eye. These sensors then transmit those signals to the brain via the optic nerve. The device helps replace the damaged cells of the retina and helps patients see images or detect movement.

"It's a start, it's a beginning," said Dr. Mark Fromer, an ophthalmologist at Lenox Hill Hospital in New York City. "It's going to be exciting for people who get this device who are currently just seeing light or dark, [they] will see shapes and that will be life-altering for them."

An FDA official was similarly enthused.

"For many of the approximately 1,300 individuals who will develop the disease this year, this technology may change their lives," Dr. William Maisel, deputy director for science and chief scientist at FDA's Center for Devices and Radiological Health, said in an agency blog post. "It's the difference between night and day," he added.

Maisel's post also included testimony from people who had tested the device and spoke in favor of its approval at a recent FDA hearing:

"The biggest thing to me was being able to see the crosswalk lines on the street so I can safely cross streets in Manhattan," one user said.

"The most exciting day to me was October 27th, in 2009," another testified. "It was the first time I was able to see letters on the monitor screen [during a test of visual perception]. I had not seen letters since 1994, so that was huge."

A third person said he had a 17-year-old son, "and I don't mind telling you how much -- I mean, how happy that made me, not only to see the silhouette of my son, but to hear that voice coming and saying, 'Yeah, it's me, Dad. I'm here and I love you.'"

People with retinitis pigmentosa suffer damage to the light-sensitive cells of the retina. As these cells slowly degenerate, patients lose side vision and night vision and later on, central vision. The disease can cause blindness,

The FDA's approval is a limited one, labeled a "humanitarian use device" approval, meaning the Argus II can be used only for fewer than 4,000 patients per year.

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FDA Approves New Blood Thinner Eliquis

Dec. 31, 2012 -- The FDA has approved the blood thinner Eliquis to prevent stroke in people with atrial fibrillation.

AFib is the most common type of irregular heartbeat and affects about 3 million Americans.

People with AFib are about five times more likely to have a stroke.

Eliquis is approved only for use in people with AFib that is not caused by a heart valve problem. People with prosthetic heart valves should not take Eliquis.

In its approval, the FDA cited a clinical trial of Eliquis in more than 18,000 people with AFib.

The results showed that people who took Eliquis twice a day had 21% fewer strokes than those on the blood thinner warfarin.

AFib raises the risk of stroke because if the heart doesn’t beat strongly and regularly, blood can pool in the heart and become more likely to form clots.

“Blood clots in the heart can cause a disabling stroke if the clots travel to the brain,” says Norman Stockbridge, MD, PhD, of the FDA’s Center for Drug Evaluation and Research. “Anti-clotting drugs lower the risk of having a stroke by helping to prevent blood clots from forming.”

Eliquis is now the third new blood thinner to be approved as an alternative to warfarin since 2010. Pradaxa, produced by Boehringer Ingelheim, was approved in 2010, and Xarelto, marketed by Johnson & Johnson and Bayer AG, was approved in 2011.

The approval of Bristol-Myers Squibb and Pfizer’s Eliquis comes six months after the agency delayed its decision on the new blood-thinning drug.

Researchers say these new alternatives to warfarin are easier to take and are believed to be safer than warfarin, also known as Coumadin.

People taking warfarin must have their blood tested regularly because the drug can raise the risk of life-threatening bleeding.

Although researchers say people taking the new types of blood thinners do not have to be monitored as closely, the risk of life-threatening bleeding is still an issue.

There is no agent that can rapidly reverse the anti-clotting effect of Eliquis and the other new-generation blood thinners.

FDA says health care professionals should counsel people taking Eliquis and other blood thinners about the symptoms of possible bleeding, such as, paleness and fatigue.

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FDA Approves Tamiflu for Infants

Dec. 21, 2012 -- Children as young as 2 weeks old may now be treated for the flu with Tamiflu.

The FDA expanded its approval today for Tamiflu to include infants under age 1 who have had symptoms of the flu, such as stuffy nose, cough, sore throat, fever, and body aches, for no longer than two days.

It is not approved to prevent flu infection in this age group.

Tamiflu is now the only drug approved to treat the flu in children under age 1, who are at higher risk of developing complications of the flu.

Until now, Tamiflu was approved to treat the flu in adults and children ages 1 year and older who have had symptoms for less than two days. The drug is also approved to prevent flu infection in children and adults over 1 year of age.

FDA officials say there is a fixed dosing schedule for children and adults over age 1, but dosing for children under 1 year old must be calculated for each infant according to their weight.

Children under age 1 should receive 3 milligrams of Tamiflu per kilogram of body weight twice daily for five days. This smaller dose requires a different dispenser than what currently comes in the Tamiflu package.

“Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight.”

According to the CDC, children younger than 2 years old are especially vulnerable to developing complications from the flu. Infants 6 months of age and younger have the highest rates of hospitalization for the flu.

The FDA based its approval of Tamiflu for children under age 1 on data from previous studies in adults and older children.

Two new safety studies in 135 children under 1 year old with confirmed cases of the flu also showed the safety profile in infants was consistent with that found among older children and adults.

The most common side effect in these studies was vomiting and diarrhea.

Rare cases of severe rash, skin reactions, hallucinations, delirium, and abnormal behavior have been reported with use of Tamiflu but were not found in these new safety studies.

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FDA Approves Tamiflu for Infants

ByJennifer Warner
WebMD Health News Reviewed byBrunilda Nazario, MD

Dec. 21, 2012 -- Children as young as 2 weeks old may now be treated for the flu with Tamiflu.

The FDA expanded its approval today for Tamiflu to include infants under age 1 who have had symptoms of the flu, such as stuffy nose, cough, sore throat, fever, and body aches, for no longer than two days.

It is not approved to prevent flu infection in this age group.

Tamiflu is now the only drug approved to treat the flu in children under age 1, who are at higher risk of developing complications of the flu.

Until now, Tamiflu was approved to treat the flu in adults and children ages 1 year and older who have had symptoms for less than two days. The drug is also approved to prevent flu infection in children and adults over 1 year of age.

Correct Dosing for Infants Essential

FDA officials say there is a fixed dosing schedule for children and adults over age 1, but dosing for children under 1 year old must be calculated for each infant according to their weight.

Children under age 1 should receive 3 milligrams of Tamiflu per kilogram of body weight twice daily for five days. This smaller dose requires a different dispenser than what currently comes in the Tamiflu package.

“Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight.”

Infants at Risk for Flu Complications

According to the CDC, children younger than 2 years old are especially vulnerable to developing complications from the flu. Infants 6 months of age and younger have the highest rates of hospitalization for the flu.

The FDA based its approval of Tamiflu for children under age 1 on data from previous studies in adults and older children.

Two new safety studies in 135 children under 1 year old with confirmed cases of the flu also showed the safety profile in infants was consistent with that found among older children and adults.

The most common side effect in these studies was vomiting and diarrhea.

Rare cases of severe rash, skin reactions, hallucinations, delirium, and abnormal behavior have been reported with use of Tamiflu but were not found in these new safety studies.

View Article Sources

SOURCES:

FDA.

News release, FDA.

WebMD Drug Information from First DataBank: “Tamiflu Oral.”

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