Wednesday March 27, 2019

FDA Approves Drug to Stop Some Malaria Relapses

Worldwide, malaria infects more than 200 million people a year and kills about half a million, most of them children in Africa

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FILE - The GlaxoSmithKline offices in London. On Friday, the U.S. Food and Drug Administration approved GlaxoSmithKline’s Krintafel, a simpler, one-dose treatment, to prevent relapses of a type of malaria. (VOA)

U.S. regulators Friday approved a simpler, one-dose treatment to prevent relapses of malaria.

Standard treatment now takes two weeks and studies show many patients don’t finish taking every dose.

Malaria is caused by parasites that are spread to people through mosquito bites. Anti-malarial drugs can cure the initial infection, but parasites can get into the liver, hide in a dormant form and cause recurrences months or years later. A second drug is used to stop relapses.

The new drug, GlaxoSmithKline’s Krintafel, only targets the kind of malaria that mainly occurs in South America and Southeast Asia. Most malaria cases and deaths are in Africa, and they involve another species.

In testing, one dose of Krintafel worked about the same as two weeks of the standard treatment, preventing relapses in about three-quarters of patients in six months, the company said.

Malaria is caused by parasites that are spread to people through mosquito bites.
Malaria is caused by parasites that are spread to people through mosquito bites. (VOA)

The Food and Drug Administration approved the drug for patients 16 and older, according to GlaxoSmithKline. The company said it’s the first new treatment in six decades for preventing relapses.

GlaxoSmithKline plans to apply soon for approval in Brazil, then other countries where the malaria type is common. It says it will sell the pills at low cost in poor countries.

Millions infected worldwide

Worldwide, malaria infects more than 200 million people a year and kills about half a million, most of them children in Africa. It causes fever, headache, chills and other flulike symptoms. The malaria type Krintafel targets causes about 8.5 million infections annually.

Also Read: Trial Wipes out More Than 80 per cent of Disease-Spreading Mosquitoes

The British drugmaker, working with the World Health Organization, is also developing what could be the world’s first malaria vaccine, but early testing indicates it’s not very effective. Prevention now focuses on using insecticides and bed nets. (VOA)

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FDA Approves Device to Treat Heart Failure Patients

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics

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The US Food and Drug Administration has given approval for a new device that would help treat patients with life-threatening heart failure, and address an unmet need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

The Optimizer Smart system is comprised of several components, including an implantable pulse generator, battery charger, programmer and software. The pulse generator is implanted under the skin in the upper left or right area of the chest and connected to three leads that are implanted in the heart.

After the device is implanted, a physician tests and programmes the device, which delivers electrical impulses to the heart during regular heartbeats to help improve the heart’s squeezing capability.

The device would be beneficial for patients not suited to treatment with other heart failure devices such as cardiac resynchronisation therapy to restore a normal timing pattern of the heartbeat, the US FDA noted in a statement.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” said Bram Zuckerman, Director at FDA’s Centre for Devices and Radiological Health.

Photo Credit: www.medscape.com

“The FDA recognised the unmet need for these patients and worked with the manufacturer…to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness,” Zuckerman added.

For the study, the US FDA evaluated data from two clinical trials with a total of 389 patients with moderate-to-severe heart failure.

All patients received optimal medical therapy and 191 patients also received an Optimizer Smart system implant.

Also Read- Microsoft to Notify Users About End of Windows 7

The Optimizer Smart system improves quality of life and functional status of certain heart failure patients.

The health body has granted approval of the Optimizer Smart system to US-based Impulse Dynamics. (IANS)