Department of Veterans Affairs, Department Of Defense Study a Major Breakthrough For Understanding PTSD

March 28, 2017

WASHINGTON — Researchers from the Department of Veterans Affairs (VA) and Department of Defense (DOD) recently released findings of a new study called Prospective Post-Traumatic Stress disorder Symptom Trajectories in Active Duty and Separated Military Personnel, which examines Post Traumatic Stress Disorder (PTSD) symptoms in Veterans, compared with active-duty populations.

This is the first known study comparing PTSD symptom trajectories of current service members with those of Veterans, and is the product of a collaborative effort from VA and DOD researchers analyzing data from the Millennium Cohort Study (MCS), the largest prospective health study of military service members.

According to VA’s National Center for PTSD, the PTSD rate among Vietnam Veterans was 30.9 percent for men and 26.9 percent for women. For Gulf War Veterans, the PTSD rate was 12.1 percent. Operation Enduring Freedom/Operation Iraqi Freedom Veterans had a PTSD rate of 13.8 percent.

“Knowing there are similarities in how PTSD affects service members and Veterans makes it easier to pinpoint which treatments are the best to control the condition,” said Dr. Edward Boyko, an epidemiologist and internist at the VA Puget Sound Health Care System in Washington state, and VA’s lead researcher on the Millennium Cohort Study.

Officials involved with the project said they are hoping the collaboration will improve the understanding of Veterans’ health needs, relative to their experiences in service.

“The data that MCS researchers have been collecting since 2001 is incredibly valuable for both the DOD and VA,” said Dr. Dennis Faix, director of the Millennium Cohort Study and preventive medicine physician. “Going forward, working with VA will allow both agencies to make sure we are getting the best information to develop a comprehensive understanding of the continuum of health in current and former service members.”

The results of the joint VA DOD study will appear in the Journal of Psychiatric Research’s June 2017 issue. It is the first of many joint future publications expected to result from the collaboration between VA and MCS.

You can learn more about the study here: http://millenniumcohort.org/.

FDA Approves New Eczema Drug Dupixent

 

March 28, 2017

SILVER SPRING, MD The U.S. Food and Drug Administration today approved Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema (atopic dermatitis). Dupixent is intended for patients whose eczema is not controlled adequately by topical therapies, or those for whom topical therapies are not advisable. Dupixent can be used with or without topical corticosteroids.

“FDA’s approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients with skin disease,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research. “Eczema can cause significant skin irritation and discomfort for patients, so it is important to have a variety of treatment options available to patients, including those patients whose disease is not controlled by topical therapies.”

Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as “eczema,” which is a general term for several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema; onset typically begins in childhood and can last through adulthood. The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy. Scratching leads to swelling, cracking, “weeping” clear fluid, and finally, coarsening and thickening of the skin.

Dupixent is administered as an injection under the skin. Dupixent’s active ingredient is an antibody (dupilumab) that binds to a protein [interleukin-4 (IL-4) receptor alpha subunit (IL-4Ra)], that causes inflammation. By binding to this protein, Dupixent is able to inhibit the inflammatory response that plays a role in the development of atopic dermatitis.

The safety and efficacy of Dupixent were established in three placebo-controlled clinical trials with a total of 2,119 adult participants with moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s). Overall, participants who received Dupixent achieved greater response, defined as clear or almost clear skin, and experienced a reduction in itch after 16 weeks of treatment.

Dupixent can cause side effects such as serious allergic reactions and eye problems, such as pink eye (conjunctivitis) and inflammation of the cornea (keratitis). If patients experience new or worsening eye symptoms such as redness, itching, pain or visual changes, they should consult a health care provider. The most common side effects include injection site reactions; cold sores in the mouth or on the lips; and eye and eyelid inflammation, including redness, swelling and itching.

The safety and efficacy of Dupixent have not been established in the treatment of asthma. Patients who also have asthma should not adjust or stop their asthma treatment without talking to their physicians.

The FDA granted the application for Dupixent Priority Review and Breakthrough Therapy designation.

The FDA granted the approval of Dupixent to Regeneron Pharmaceuticals, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

WOMEN’S HEALTH ALERT – Public Meeting on Patient-Focused Drug Development for Sarcopenia

On April 6, 2017, from 1:00 pm to 5:00 pm, FDA is conducting a public meeting on Patient-Focused Drug Development (PFDD) for Sarcopenia. FDA is interested in obtaining patient perspectives on the impact of sarcopenia on daily life and patient views on treatment approaches. Registration to attend the meeting must be received by April 6, 2017.

In addition to providing input at the public meeting, stakeholders are invited to provide their perspectives on the discussion questions through the public docket. The docket closes on June 6, 2017.

Register for the meeting

Submit comments to the public docket

Sarcopenia, or the decline of skeletal muscle tissue with age, is one of the most important causes of functional decline and loss of independence in older adults.

FDA grants accelerated approval to new treatment for advanced ovarian cancer

December 19, 2016

Silver Spring, MD – The U.S. Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. Rubraca is approved for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test.

“Today’s approval is another example of the trend we are seeing in developing targeted agents to treat cancers caused by specific mutations in a patient’s genes,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and acting director of the FDA’s Oncology Center of Excellence. “Women with these gene abnormalities who have tried at least two chemotherapy treatments for their ovarian cancer now have an additional treatment option.”

The National Cancer Institute estimates that 22,280 women will be diagnosed with ovarian cancer in 2016 and an estimated 14,240 will die of this disease. Approximately 15 to 20 percent of patients with ovarian cancer have a BRCA gene mutation.

BRCA genes are involved with repairing damaged DNA and normally work to prevent tumor development. However, mutations of these genes may lead to certain cancers, including ovarian cancers. Rubraca is a poly ADP-ribose polymerase (PARP) inhibitor that blocks an enzyme involved in repairing damaged DNA. By blocking this enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth.

Today, the FDA also approved the FoundationFocus CDxBRCA companion diagnostic for use with Rubraca, which is the first next-generation-sequencing (NGS)-based companion diagnostic approved by the agency. The NGS test detects the presence of deleterious BRCA gene mutations in the tumor tissue of ovarian cancer patients. If one or more of the mutations are detected, the patient may be eligible for treatment with Rubraca.

The safety and efficacy of Rubraca were studied in two, single-arm clinical trials involving 106 participants with BRCA-mutated advanced ovarian cancer who had been treated with two or more chemotherapy regimens. BRCA gene mutations were confirmed in 96 percent of tested trial participants with available tumor tissue using the FoundationFocus CDxBRCA companion diagnostic. The trials measured the percentage of participants who experienced complete or partial shrinkage of their tumors (overall response rate). Fifty-four percent of the participants who received Rubraca in the trials experienced complete or partial shrinkage of their tumors lasting a median of 9.2 months.

Common side effects of Rubraca include nausea, fatigue, vomiting, low levels of red blood cells (anemia), abdominal pain, unusual taste sensation (dysgeusia), constipation, decreased appetite, diarrhea, low levels of blood platelets (thrombocytopenia) and trouble breathing (dyspnea).  Rubraca is associated with serious risks, such as bone marrow problems (myelodysplastic syndrome), a type of cancer of the blood called acute myeloid leukemia and fetal harm.

The agency approved Rubraca under its accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease or condition based on clinical data showing the drug has an effect on a surrogate (substitute) endpoint that is reasonably likely to predict clinical benefit. The sponsor is continuing to study this drug in patients with advanced ovarian cancer who have BRCA gene mutations and in patients with other types of ovarian cancer. The FDA also granted the Rubraca application breakthrough therapy designation and priority review status. Rubraca also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs intended to treat rare diseases.

Rubraca is marketed by Clovis Oncology, Inc. based in Boulder, Colorado. The FoundationFocus CDxBRCA companion diagnostic is marketed by Foundation Medicine, Inc. of Cambridge, Massachusetts.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Approves Eucrisa for Atopic Eczema

December 14, 2016

Silver Springs, MD – The U.S. Food and Drug Administration today approved Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older.

Atopic dermatitis, a chronic inflammatory skin disease, is often referred to as “eczema,” which is a general term for the several types of inflammation of the skin. Atopic dermatitis is the most common of the many types of eczema and onset typically begins in childhood and can last through adulthood. The cause of atopic dermatitis is a combination of genetic, immune and environmental factors. In atopic dermatitis, the skin develops red, scaly and crusted bumps, which are extremely itchy. Scratching leads to swelling, cracking, “weeping” clear fluid, and finally, coarsening and thickening of the skin.

“Today’s approval provides another treatment option for patients dealing with mild to moderate atopic dermatitis,” said Amy Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER).

Eucrisa, applied topically twice daily, is a phosphodiesterase 4 (PDE-4) inhibitor, although its specific mechanism of action in atopic dermatitis is not known.

The safety and efficacy of Eucrisa were established in two placebo-controlled trials with a total of 1,522 participants ranging in age from two years of age to 79 years of age, with mild to moderate atopic dermatitis. Overall, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment.

Serious side effects of Eucrisa include hypersensitivity reactions. Eucrisa should not be used in patients who have had a hypersensitivity reaction to Eucrisa’s active ingredient, crisaborole. The most common side effect of Eucrisa is application site pain, including burning or stinging.

Eucrisa is manufactured by Palo Alto, California-based Anacor Pharmaceuticals, Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

How to Treat Impetigo and Control This Common Skin Infection

 

It’s a scary sight when your child comes home from day care or elementary school with red sores and oozing fluid-filled blisters. Don’t be alarmed if it’s impetigo. Impetigo — one of the most common childhood diseases — can be treated with medications approved by the U.S. Food and Drug Administration (FDA).

Impetigo is a common bacterial skin infection that can produce blisters or sores anywhere on the body, but usually on the face (around the nose and mouth), neck, hands, and diaper area. It’s contagious, preventable, and manageable with antibiotics, says pediatrician Thomas D. Smith, MD, of FDA.

What causes Impetigo

Two types of bacteria found on our skin cause impetigo: Staphylococcus aureus and Streptococcus pyogenes (which also causes strep throat). Most of us go about our lives carrying around these bacteria without a problem, Smith says. But then a minor cut, scrape or insect bite allows the bacteria to cause an infection, resulting in impetigo.

Anyone can get impetigo — and more than once, Smith says. Although impetigo is a year-round disease, it occurs most often during the warm weather months. There are more than 3 million cases of impetigo in the United States every year.

“We typically see impetigo with kids 2 to 6 years old, probably because they get more cuts and scrapes and scratch more. And that spreads the bacteria,” Smith says.

Treating Impetigo

Look for these signs of impetigo:

• itchy red sores that fill with fluid and then burst open, forming a yellow crust
• itchy rash
• fluid-filled blisters

If you see those symptoms, visit your health care provider. Impetigo is usually treated with topical or oral antibiotics. If you have multiple lesions or if there is an outbreak, your doctor might prescribe an oral antibiotic. There is no over-the-counter (OTC) treatment for impetigo.

Controlling and Preventing Impetigo

Untreated, impetigo often clears up on its own after a few days or weeks, Smith says. The key is to keep the infected area clean with soap and water and not to scratch it. The downside of not treating impetigo is that some people might develop more lesions that spread to other areas of their body.

And you can infect others. “To spread impetigo, you need fairly close contact — not casual contact — with the infected person or the objects they touched,” he says. Avoid spreading impetigo to other people or other parts of your body by:

• Cleaning the infected areas with soap and water.
• Loosely covering scabs and sores until they heal.
• Gently removing crusty scabs.
• Washing your hands with soap and water after touching infected areas or infected persons.

Because impetigo spreads by skin-to-skin contact, there often are small outbreaks within a family or a classroom, Smith says. Avoid touching objects that someone with impetigo has used, such as utensils, towels, sheets, clothing and toys. If you have impetigo, keep your fingernails short so the bacteria can’t live under your nails and spread. Also, don’t scratch the sores.

Call your health care provider if the symptoms don’t go away or if there are signs the infection has worsened, such as fever, pain, or increased swelling.

This article appears on the FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.