US FDA Current Affairs - 2019

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PRETOMANID: US FDA approves new drug for drug-resistant TB

United States (US) Food and Drug Administration (FDA) has approved new drug-Pretomanid for treating drug-resistant strain of Tuberculosis (TB). Pretomanid is novel compound developed by New York-based non-profit organisation TB Alliance. It is used alongside two other antibiotics (bedaquiline and linezolid) to treat extremely drug-resistant strain of tuberculosis. This three-drug regimen is collectively known as BPaL regimen and it can cure highly drug-resistant strains of tuberculosis by drastically shortening treatment period.

Significance of BPaL regimen

Before FDA approval to this combination therapy, the most common treatment used for extremely drug resistace tuberculosis required patients to take around 30 pills day plus sometimes daily injections for at least 18 months. This new treatment lowers that dose to 5 pills/day over 6 months for most patients. This treatment regimen had achieved 90% success rate during six months of treatment and six months of post-treatment follow-ups after it was tested on 109 patients at three sites in South Africa.

US approves first test to screen Zika virus in donated blood

United States Food and Drug Administration (FDA) has approved ‘Cbas Zika test’ for detecting Zika virus in donated blood. It is first of kind test approved by FDA for detecting Zika virus in donated blood.

The cobas Zika test is manufactured by Roche Molecular Systems Inc. It is intended for use by blood collection establishments to detect Zika virus in blood donations and not for individual diagnosis of Zika virus infection.

Cobas Zika test

It is qualitative nucleic acid test for detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components and from living organ donors. It has shown more than 99% clinical specificity, in earlier evaluation for testing individual samples from blood donations at five external laboratories

Zika virus

Zika virus is vector borne disease transmitted primarily by Aedes aegypti mosquitoes, the same mosquito that transmits dengue. It can also spread through blood transfusion and sexual contact.

The virus is capable of causing serious birth defects i.e. neurological disorders and foetal deformation known as Microcephaly in which infants are born with abnormally smaller heads. Besides a possible link between virus and Guillain-Barré syndrome (a condition in which the body’s immune system attacks part of the nervous system) is also suspected.

There is no specific treatment or vaccine currently available to treat Zika. The best form of prevention is protection against mosquito bites and clearing stagnant water where mosquitoes breed.