USFDA

USFDA just approved the world’s first ‘artificial pancreas’

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The FDA just approved a device that’s often referred to as an ‘artificial pancreas’. The device, made by Medtronic, is called the MiniMed 670G.

It’s been approved for people with type 1 diabetes over the age of 14. It works by automatically monitoring a person’s blood sugar levels and administering insulin as needed – no constant checking and injecting required.

Diabetes is a condition in which people have a hard time processing sugar. Type 1, in particular, is an autoimmune disease in which the body mistakenly kills cells that are supposed to make insulin, a hormone that helps people absorb and process the sugar in food.

Insulin is produced and released through the pancreas – that’s where the term ‘artificial pancreas’ comes in.

Roughly 1.25 million people in the US have type 1 diabetes. These patients often opt to have an insulin pump that can administer insulin as needed throughout the day.

Some also buy a glucose monitor, which is used to continuously monitor blood sugar levels; that way a diabetic can know if their levels are going too low or too high and find a way to correct it.

In contrast, the MiniMed 670G, referred to as a ‘hybrid closed loop’ system, is what Jeffrey Shoorin of the FDA said in a statement is a “first-of-its-kind technology”: the first approved system that combines both the glucose monitor and the insulin pump in one device.

According to the FDA, the device measures blood sugar every five minutes, then responds by sending insulin into the body, or holding steady. Diabetics can also manually request insulin around mealtimes.

A clinical trial of the MiniMed 670G involving 123 people with type 1 diabetes had no serious adverse events, though the FDA notes that “risks may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch.”

While the device is approved as of today, Medtronic will do additional testing to see how well it works in real-life situations. The company is also conducting additional trials to see if it can be used in children 7 to 14 years old.

“We are committed to preparing for commercial launch as quickly as possible,” Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic, said in a statement.

Here’s what the device looks like:

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USFDA approves CLOT Retrieval Devices to help with STROKE

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The U.S. Food and Drug Administration today allowed marketing of two Trevo clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug (tissue plasminogen activator or t-PA), which needs to be given within three hours of symptom onset.

“This is the first time FDA has allowed the use of these devices alongside t-PA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of t-PA alone,” said Carlos Peña, Ph.D., director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. “Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability.”

The Trevo device was first cleared by the FDA in 2012 to remove a blood clot and restore blood flow in stroke patients who could not receive t-PA or for those patients who did not respond to t-PA therapy. Today’s action expands the devices’ indication to a broader group of patients.

Trevo is a clot removal device that is inserted through a catheter up into the blood vessel to the site of the blood clot. When the shaped section at the end of the device is fully expanded (up to three to six millimeters in diameter), it grips the clot, allowing the physician to retrieve the clot by pulling it back through the blood vessel along with the device for removal through a catheter or sheath.

Stroke kills nearly 130,000 Americans each year and is the fifth leading cause of death, according to the Centers for Disease Control and Prevention. About 87 percent of all strokes are ischemic strokes. Until now, the only first-line treatment for acute ischemic stroke was t-PA administered intravenously.

The FDA evaluated data from a clinical trial comparing 96 randomly selected patients treated with the Trevo device along with t-PA and medical management of blood pressure and disability symptoms with 249 patients who had only t-PA and medical management. Twenty-nine percent of patients treated with the Trevo device were functionally independent (ranging from no symptoms to slight disability) three months after their stroke, compared to 19 percent of patients who were not treated with the Trevo device.

Risks associated with using the Trevo device include a failure to retrieve the blood clot, device malfunctions including breakage and navigation difficulties, which can potentially damage blood vessels and cause perforation or hemorrhage.

The FDA reviewed the data for Trevo for stroke treatment through the de novo premarket review pathway, a regulatory pathway for devices of a new type with low-to-moderate-risk that are not substantially equivalent to an already legally-marketed device and for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices.

Trevo is manufactured by Concentric Medical Inc. in Mountain View, California.

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USFDA has given fast track approval for THIS cancer drug

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A new cancer drug called Venetoclax is causing quite a stir in the medical community, with the announcement that the US FDA has given it fast-track approval for the treatment of patients with chronic lymphocytic leukemia (CLL).

CLL is one of the most common types of leukemia in adults, and during a recent clinical trial, 80 percent of patients treated with Venetoclax experienced complete or partial remission of their cancer. 

Developed in Australia over several decades, Venetoclax is taken in pill-form, and of the small sample of patients who have been treated with it so far, some reported no adverse side-effects at all.

“It causes no side-effects. Nothing, absolutely nothing,” Robert Oblak, who had recurring CLL when he was selected to participate in the trial in 2013, told the ABC. “Quite amazing. So even when it’s killing cells, you feel great.”

Oblak estimates that he was just the 11th person in the world to be treated with Venetoclax, and within a year of treatment, he went into remission. 

The phase II trial involved 107 patients aged 18 or older with CLL, who had undergone at least one type of treatment already. 

The patients also had to have a particular chromosome abnormality in their leukemia cells called 17p deletion, which means they’re lacking a portion of the chromosome that acts to suppress cancer growth. 

They were asked to take one Venetoclax pill per day for five weeks straight, with doses starting at 20 mg and gradually increasing to 400 mg

At the end of the trial, which involved patients and researchers from 31 centres in the US, Canada, the UK, Germany, Poland, and Australia, four out of five patients experienced a positive result, with complete remission reported for one in five.

“These patients now have a new, targeted therapy that inhibits a protein involved in keeping tumour cells alive,” Richard Pazdur from the FDA’s Centre for Drug Evaluation and Research, announced back in April. 

“For certain patients with CLL who have not had favourable outcomes with other therapies, Venclexta may provide a new option for their specific condition.”

The results of the trial, which were published in The Lancet in June, informed the FDA’s decision to fast-track approval of the drug and make it available to patients in the US. 

Despite being developed by researchers at Australia’s Walter and Eliza Hall Institute of Medical Research, it’s not yet been approved for use by Australian patients, but an application has been made.

So, how does the drug work? Venetoclax is one of a new generation of immunotherapy cancer drugs that are designed to address certain failings of a person’s own immune system – such as missing portions of chromosomes that inhibit the cells’ ability to fight the spread of cancer.

In CLL patients with 17p deletion, malignant cells don’t proliferate all that much, but they don’t die, because the body’s immune response has been hindered, and abundant levels of a protein called BCL2 helps keep them alive.

“Cells, when they are born, are destined to die and cancer cells and particularly leukaemia cells delay that death by using a protein called BCL2 that stops the normal time of death,” John Seymour from the Peter MacCallum Cancer Centre in Melbourne, who helped oversee the trial, told the ABC.

“Venetoclax works by specifically blocking the action of that BCL2, and allows the cells to die in the way that they were destined to.”

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So rather than killing off the cancer cells – and a bunch of healthy cells in the vicinity – like current treatments like chemo and radiotherapy do, the drug reestablishes the balance of the body’s immune system, and effectively allows the cancer cells to die on their own.

This explains why some patients, like Oblak can undergo treatment with no discernible side-effects. But let’s be clear – Oblak was very lucky. 

The FDA reports that, depending on the patient, side-effects from Venetoclax include low white blood cell count, diarrhoea, nausea, anaemia, upper respiratory tract infection, low platelet count, and fatigue. Serious complications can include pneumonia, fever, and death.

During the Venetoclax trial, of the 107 patients, 11 ended up dying, seven because of the progression of their cancer, and four from adverse side-effects. 

Similar results were seen in a separate trial of a similar immunotherapy cancer drug, Ipilimumab, which has recently been approved for the Australian market. 

While Australian patient Greg Lawson was declared free from melanomas 12 months after treatment, and reportedly suffered “virtually no side-effects”, his wife, who was treated with a different melanoma immunotherapy drug at the same time, died when her body could not tolerate the treatment.

“She had two sets of the treatment, but was so ill from the side-effects that the decision was made to take her off it,” Lawson told the ABC.

But with immunotherapy drugs seeing “extraordinary” results in other trials this year, and with the possibility of a ‘universal cancer vaccine’ hanging in the air, this is just the beginning for the next generation of cancer treatment. 

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USFDA approves computerised congnitive tests for head injury

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The U.S. Food and Drug Administration  permitted marketing of two new devices to assess a patient’s cognitive function immediately after a suspected brain injury or concussion. The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric are the first medical devices permitted for marketing that are intended to assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.

ImPACT and ImPACT Pediatric are not intended to diagnose concussions or determine appropriate treatments. Instead the devices are meant to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury. The results are compared to an age-matched control database or to a patient’s pre-injury baseline scores, if available.

“These devices provide a useful new tool to aid in the evaluation of patients experiencing possible signs of a concussion, but clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game,” said Carlos Peña, Ph.D., M.S., director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health.

ImPACT software runs on a desktop or laptop and is intended for those ages 12 to 59, while the ImPACT Pediatric runs on an iPad and is designed for children ages 5 to 11. Only licensed health care professionals should perform the test analysis and interpret the results.

Traumatic brain injuries account for more than 2 million emergency room visits in the United States each year, according to the U.S. Centers for Disease Control and Prevention, and contribute to the deaths of more than 50,000 Americans. A significant percentage of these injuries are considered to be mild. A concussion is considered to be a mild traumatic brain injury.

The manufacturer submitted over 250 peer-reviewed articles, of which half were independently conducted clinical research studies. The research publications analyzed the scientific value of the ImPACT devices including the devices’ validity, reliability and ability to detect evidence of cognitive dysfunction that might be associated with a concussive head injury. The FDA concluded that these studies provide valid scientific evidence to support the safety and effectiveness of the ImPACT and ImPACT Pediatric devices.

The FDA reviewed the ImPACT device through its de novo classification process, a regulatory pathway for novel, low- to-moderate-risk medical devices that are first-of-a-kind, for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices. The device is manufactured by ImPACT Applications, located in Pittsburgh, Pennsylvania.

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USFDA approves Adlyxin to treat type 2 diabetes

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The U.S. Food and Drug Administration approved Adlyxin (lixisenatide), a once-daily injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.

“The FDA continues to support the development of new drug therapies for diabetes management,” said Mary Thanh Hai Parks, M.D., deputy director, Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Adlyxin will add to the available treatment options to control blood sugar levels for those with type 2.”

Type 2 diabetes affects more than 29 million people and accounts for more than 90 percent of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage.

Adlyxin is a glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels. The drug’s safety and effectiveness were evaluated in 10 clinical trials that enrolled 5,400 patients with type 2 diabetes. In these trials, Adlyxin was evaluated both as a standalone therapy and in combination with other FDA-approved diabetic medications, including metformin, sulfonylureas, pioglitazone and basal insulin. Use of Adlyxin improved hemoglobin A1c levels (a measure of blood sugar levels) in these trials.

In addition, more than 6,000 patients with type 2 diabetes at risk for atherosclerotic cardiovascular disease were treated with either Adlyxin or a placebo in a cardiovascular outcomes trial. Use of Adlyxin did not increase the risk of cardiovascular adverse events in these patients.

Adlyxin should not be used to treat people with type 1 diabetes or patients with increased ketones in their blood or urine (diabetic ketoacidosis).

The most common side effects associated with Adlyxin are nausea, vomiting, headache, diarrhea and dizziness. Hypoglycemia in patients treated with both Adlyxin and other antidiabetic drugs such as sulfonylurea and/or basal insulin is another common side effect. In addition, severe hypersensitivity reactions, including anaphylaxis, were reported in clinical trials of Adlyxin.

The FDA is requiring the following post-marketing studies for Adlyxin:

  • Clinical studies to evaluate dosing, efficacy and safety in pediatric patients.
  • A study evaluating the immunogenicity of lixisenatide.

Adlyxin is manufactured by Sanofi-Aventis U.S. LLC, of Bridgewater, New Jersey.