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The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.

“Today’s approval represents a significant shift in the treatment paradigm for some patients with chronic hepatitis C,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

Sovaldi is the second drug approved by the FDA in the past two weeks to treat chronic HCV infection. On November 22, the FDA approved Olysio (simeprevir).

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take several years. Some people with chronic HCV infection develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with HCV.

Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. There are several different types of HCV infection. Depending on the type of HCV infection a patient has, the treatment regimen could include Sovaldi and ribavirin or Sovaldi, ribavirin and peginterferon-alfa. Ribavirin and peginterferon-alfa are two drugs also used to treat HCV infection.

Sovaldi’s effectiveness was evaluated in six clinical trials consisting of 1,947 participants who had not previously received treatment for their disease (treatment-naive) or had not responded to previous treatment (treatment-experienced), including participants co-infected with HCV and HIV. The trials were designed to measure whether the hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s HCV infection has been cured.

Results from all clinical trials showed a treatment regimen containing Sovaldi was effective in treating multiple types of the hepatitis C virus. Additionally, Sovaldi demonstrated efficacy in participants who could not tolerate or take an interferon-based treatment regimen and in participants with liver cancer awaiting liver transplantation, addressing unmet medical needs in these populations.

The most common side effects reported in clinical study participants treated with Sovaldi and ribavirin were fatigue and headache. In participants treated with Sovaldi, ribavirin and peginterferon-alfa, the most common side effects reported were fatigue, headache, nausea, insomnia and anemia.

Sovaldi is the third drug with breakthrough therapy designation to receive FDA approval. The FDA can designate a drug as a breakthrough therapy at the request of the sponsor if preliminary clinical evidence indicates the drug may demonstrate a substantial improvement over available therapies for patients with serious or life-threatening diseases. Sovaldi was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness.

Sovaldi is marketed by Gilead, based in Foster City, Calif. Olysio is marketed by Raritan, N.J.-based Janssen Pharmaceuticals.

This Press Release is Courtesy of www.FDA.gov

Today the U.S. Food and Drug Administration allowed marketing of four diagnostic devices that can be used for high throughput gene sequencing, often referred to as “next generation sequencing” (NGS). These instruments, reagents, and test systems allow labs to sequence a patient’s DNA (deoxyribonucleic acid).

The new technology also gives physicians the ability to take a broader look at their patients’ genetic makeup and can help in diagnosing disease or identifying the cause of symptoms.

“NGS is changing the way we look at genomics,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “Before NGS, sequencing genes associated with a particular disease was a long and costly process. Today, we have the capability to read and interpret large segments of DNA very quickly in a single test and this information-rich technology is becoming more accessible for use by physicians in the care of their patients.”

Two of the newly cleared devices are used to detect DNA changes in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, which can result in cystic fibrosis (CF), an inherited chronic disease that affects the lungs, pancreas, liver, intestines, and other organs of those who inherit a faulty CFTR gene from both parents.

More than 10 million Americans are CF carriers and approximately 30,000 children and adults in the U.S. are affected with CF. Most children with CF are diagnosed by age 2 and the average life span for people with CF who live to adulthood is approximately 37 years.

The cleared devices include:

The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay, which checks specific points in the patient’s CFTR gene sequence to detect known variants in the gene. Information about which DNA changes are associated with symptoms of cystic fibrosis is found in the Clinical and Functional TRanslation of CFTR database (CFTR2 disclaimer icon ).
The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, which sequences a large portion of the CFTR gene to detect any difference in the CFTR gene compared to a reference CFTR gene.

Data submitted by Illumina for their cystic fibrosis tests included comparisons of the sequence results to Human Genome Build 19, a reference representation of the human genome. In addition, Illumina evaluated the performance of its instrument and reagent systems against a publically available quality-weighted human reference genome that was created through collaboration between the FDA and the National Institutes of Standards and Technology (NIST).
FDA authorized sequencing devices provide labs with quality and performance information

The FDA also granted de novo petitions for the Illumina MiSeqDx instrument platform and the Illumina Universal Kit reagents, two devices that make up the first FDA-regulated test system that allows laboratories to develop and validate sequencing of any part of a patient’s genome. The Universal Kit reagents isolate and create copies of genes of interest obtained from patient blood samples, and the MiSeqDx platform analyzes the genes. The software compares the patient’s genomic sequence to a reference sequence and reports back any differences between the patient and the reference.

“The FDA’s review of the MiSeqDx and sequencer and Universal Kit reagents provides clinical laboratories with information about the expected performance of the device and the quality of the results,” said Dr. Gutierrez. “This information was not previously available for next generation sequencers, and, with this platform, labs can develop tests for clinical use with greater confidence because they use FDA authorized devices.”

The FDA reviewed the Illumina MiSeqDx instrument platform and the Illumina Universal Kit reagents through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.

For the de novo petitions, the FDA based its decision on the demonstrated performance of the MiSeqDx instrument and Universal Kit reagent systems across numerous genomic segments spanning 19 human chromosomes.

Illumina MiSeqDx instrument platform, Universal Kit reagents, MiSeqDx Cystic Fibrosis 139-Variant Assay, and MiSeqDx Cystic Fibrosis Clinical Sequencing Assay are manufactured by Illumina, Inc. in San Diego, Calif.

This Press Release is Courtesy of USFDA

“I’ve assigned my team to see what can we do to close some of the holes and gaps in the law, because my intention is to lift up and make sure the insurance that people buy is effective, that it’s actually going to deliver what they think they’re purchasing. Because what we know is, before the law was passed, a lot of these plans people thought they had insurance coverage and then they’d find out that they had huge out-of-pocket expenses or women were being charged more than men. If you had preexisting conditions, you just couldn’t get it at all.

“And we are proud of the consumer protections we’ve put into place. On the other hand, we also want to make sure that nobody is put in a position where their plans have been canceled, they can’t afford a better plan even though they’d like to have a better plan. And so we’re going to have to work hard to make sure that those folks are taken care of.” – President Barack Obama, November 7, 2013

Today, the majority of Americans have employer-based health insurance that is already providing them quality health care coverage. The Affordable Care Act strengthens employer coverage while creating new protections for people in the individual market – preventing them from being charged more because of a pre-existing condition or getting fewer benefits like mental health services or prescription drugs.

The new Health Insurance Marketplace will help millions of hard-working Americans find affordable health insurance. Premiums are, on average, 16 percent below what was originally projected. Nearly one in four insurers offering health plans through the Marketplace are selling to individuals for the first time. And a recent study found that an estimated 17 million Americans can get discounts on their premiums through the Marketplace, through tax credits.

The law aimed to make Marketplace coverage optional for the less than 5 percent of Americans who have individual market coverage that they want to keep. Health plans that consumers had when the law was passed in 2010 are “grandfathered” in and do not have to adopt most of the new consumer protections. But, in order to provide consumers with better protections and coverage, health insurers in the individual and small group markets have to adopt consumer protections for any new plans purchased after 2010. In some instances, they are adopting those protections by canceling current policies and replacing them with new and sometimes more costly plans.

Many consumers receiving these cancellation letters will be able to find a better deal with financial assistance or better coverage through the Health Insurance Marketplace, but we know a small slice of these consumers may not be eligible for a plan at a more affordable price. Last week President Obama directed his team to explore administrative actions that could be taken to help these consumers who are receiving cancellation letters.
To meet that commitment, today, HHS is using its administrative authority to:

• Allow insurers to renew their current policies for current enrollees without adopting the 2014 market rule changes. This will give consumers in the individual and small group markets the choice of staying in their plan or joining a new Marketplace plan next year. HHS will consider the impact of this transitional policy in assessing whether to extend it beyond 2014.

• Require insurers offering such renewals to ensure consumers are informed about their options. Specifically, insurers offering these renewals must inform all consumers who either already have or will receive cancellation letters about the protections their renewed plan will not include and how they can learn about the new options available to them through the Marketplaces which will offer better protections and possible financial assistance.
• To protect against the potential impacts this change will have on premiums, HHS will adjust the temporary risk corridor program which is designed to stabilize premiums as changes are implemented.

Whether an individual can keep their current plan will also depend on their insurance company and State insurance commissioner – but today’s action means that it will no longer be implementation of the law that is forcing them to buy a new plan. Turnover is high in the individual market, with 50 to 67 percent of enrollees staying for a year or less. This means that the number of people in these bare-bones policies will decrease over time. As such, this action provides a smoother transition in a market that’s generally used as a bridge by most consumers. And, this action will not allow these older plans to be sold to new customers in 2014, which would undermine the Marketplace and drive up premiums for millions of hard-working Americans. In short, this administration solution will give consumers more information and choices, including keeping their old plans. As he has said since he signed the bill into law, the President is willing to work with members of Congress in either party on good-faith, constructive solutions that strengthen the law by pursuing the same goals as this Administrative action and do not seek to undermine or repeal the law as a whole.

THIS PRESS RELEASE IS PROVIDED BY WHITEHOUSE.GOV

Rights & Protections

Whether you need health coverage or have it already, the health care law offers new rights and protections that make coverage fairer and easier to understand. Some rights and protections apply to plans in the Health Insurance Marketplace or other individual insurance, some apply to job-based plans, and some apply to all health coverage. These rights and protections provide even more choice and control over your health coverage when key parts of the law take effect in 2014. The health care law protects you in these areas:

•Creates the Health Insurance Marketplace, a new way for individuals, families, and small businesses to get health coverage
•Requires insurance companies to cover people with pre-existing health conditions
•Helps you understand the coverage you’re getting
•Holds insurance companies accountable for rate increases
•Makes it illegal for health insurance companies to arbitrarily cancel your health insurance just because you get sick
•Protects your choice of doctors
•Covers young adults under 26
•Provides free preventive care
•Ends lifetime and yearly dollar limits on coverage of essential health benefits
•Guarantees your right to appeal

COURTESY: US DEPARTMENT OF HEALTH & HUMAN SERVICES

There is a reported shortage of vaccines for the upcoming flu season. Many medical experts have expressed concern that if stock piles of vaccines are not increased before the winter is here, it might lead to an epidermic beyond imaginable proportions.