Saturday October 20, 2018

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)
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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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First Self-Assisted Hearing Aid Approved by The FDA

The FDA reviewed data from clinical studies of 125 patients, showing that outcomes with self-fitting of the device are comparable on average to those with a professional fitting of the same device

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An 85-year-old Nepalese man is seen fitted with a hearing aid, in Kathmandu, Nepal, April 12, 2017. VOA

The US Food and Drug Administration (FDA) on Friday allowed the marketing of a new hearing aid device that can amplify sounds for individuals 18 years or older with perceived mild to moderate hearing loss.

It is the first hearing aid approved by the agency that enables users to fit, programme and control the hearing aid on their own, without assistance from a health care provider, Xinhua news agency reported.

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Hearing loss, permanent or temporary, can be caused by aging, exposure to loud noises, certain medical conditions and other factors. Individuals with permanent hearing loss can use hearing aids to help them hear the speech and sounds.

The Bose Hearing Aid is a user-fitted wireless air conduction hearing aid, according to FDA.

Air conduction hearing aids can capture sound vibrations through one or more microphones and the signal is processed, amplified, and played back through an earphone placed in the ear canal.

FDA
A hearing aid (representative Image). Wikimedia

Patients can adjust the hearing aid through a mobile application on their phone. This technology enables users to fit the hearing aid settings themselves, in real-time and in real-world environments without the assistance of a health care professional.

Also Read: Eat Right Amount of Good Fat to Stay Healthy

The FDA reviewed data from clinical studies of 125 patients, showing that outcomes with self-fitting of the device are comparable on average to those with professional fitting of the same device with respect to the amount of amplification selected, speech in noise testing and overall benefit. (IANS)

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