Lupin gets CDSCO panel okay to manufacture, market tuberculosis drug Rifapentine
New Delhi: Drug major, Lupin has got a go-head from the Subject Expert Committee (SEC) of the Central Drug Standard Control Organization to (CDSCO) manufacture and market Rifapentine Tablets 300mg for the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in adults and children 2 years and older who are at high risk of progression to tuberculosis disease.
This came in the wake of the proposal presented by drug-maker Lupin for the manufacturing and marketing of antibiotic drug Rifapentine Tablet along with a bioequivalence study report to the committee.
Tuberculosis (TB) is caused by a bacterium called Mycobacterium tuberculosis which usually attacks the lungs, but TB bacteria can attack any part of the body such as the kidney, spine, and brain.
In active tuberculosis, the bacteria multiply in the body, causing noticeable symptoms. This is also when the disease can spread to others. When the TB bacteria live in the body without making one sick, it is called a "latent TB infection."
Rifapentine belongs to a class of medications called antibiotics, which work by killing the bacteria that cause infection. It inhibits DNA-dependent RNA polymerase activity in susceptible cells. It is used with other medications to treat active tuberculosis (TB) in adults and children 12 years of age and older.
It is also used with isoniazid (Laniazid) to treat adults and children 2 years of age and older with latent (resting or nongrowing) TB, including those in close contact with people who have active TB, a positive tuberculin skin test, human immunodeficiency virus (HIV), or those with pulmonary fibrosis.
The said drug is not advised to be used alone to treat people with active or latent TB or in people with active TB who have taken the medicines rifampin or isoniazid in the past and did not respond (resistant).
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Rifapentine has a very broad spectrum of activity against most gram-positive and gram-negative organisms (including Pseudomonas aeruginosa) and specifically Mycobacterium tuberculosis. It must always be used in combination with other tuberculosis medications. The medication is taken by mouth with food, usually once or twice weekly.
This drug should be used with food to prevent adverse effects such as stomach discomfort, nausea, and vomiting, as well as improve absorption. Patients who are allergic to rifapentine, rifabutin (Mycobutin), or rifampin should not take this drug.
At the 109th SEC meeting for antimicrobials and antivirals, held at CDSCO on February 23rd and 24th, 2022, the committee thoroughly examined the proposal presented by Lupin.
After detailed deliberation, the committee recommended the grant of permission to manufacture and market Rifapentine Tablets 300mg for an already approved indication, i.e. "For the treatment of latent tuberculosis infection caused by Mycobacterium tuberculosis in adults and children 2 years and older who are at high risk of progression to tuberculosis disease (including those in close contact with active tuberculosis patients, recent conversion to a positive tuberculin skin test, HIV-infected patients, or those with pulmonary fibrosis on radiograph).
In addition, the committee further noted that active tuberculosis disease should be ruled out before initiating treatment for latent tuberculosis infection. Rifapentine tablets of 150mg must always be used in combination with isoniazid as a 12-week once-weekly regimen for the treatment of latent tuberculosis infection.
