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Who makes SIRTURO?

Who makes SIRTURO?

TITUSVILLE, NJ, August 9, 2019 — The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted approval for SIRTURO® (bedaquiline) tablets as part of combination therapy in pediatric patients – those over the age of 12 and younger than 18 and …

Who invented Bedaquiline?

Bedaquiline was described for the first time in 2004 at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) meeting, after the drug had been in development for over seven years. It was discovered by a team led by Koen Andries at Janssen Pharmaceutica.

Where can I get SIRTURO?

SIRTURO® is available by prescription from healthcare professionals associated with qualified centers for the evaluation, diagnoses, and treatment of TB, including pulmonary MDR-TB. Qualified centers include public health departments, clinics that treat TB, and hospitals and institutions with a TB concentration.

What class of drug is Bedaquiline?

Bedaquiline is a member of the diarylquinoline class of drugs and has a unique mechanism of action, targeting the adenosine triphosphate (ATP) synthase enzyme of the TB mycobacteria.

What are the side effects of bedaquiline?

Common side effects of Sirturo include:

  • nausea.
  • joint pain.
  • headache.
  • coughing up blood.
  • chest pain.
  • weight loss.
  • rash.
  • increased transaminases and blood amylase.

How much does bedaquiline cost?

The Union welcomes the announcement that bedaquiline will be made available to Stop TB Partnership’s Global Drug Facility at a price of USD$340 per six-month treatment course for more than 135 eligible low- and middle-income countries.

How much does Bedaquiline cost?

Is Bedaquiline available in India?

Background: India accounts for a quarter of the world’s multidrug-resistant tuberculosis (MDR-TB); with less than 50% having successful treatment outcomes. Bedaquiline (BDQ) was approved for use under conditional access program in India in 2015.

What is bedaquiline used for?

Bedaquiline fumarate (Sirturo™) is approved by the U.S. Food and Drug Administration (FDA) for use as part of a combination therapy in adults with pulmonary multidrug-resistant tuberculosis (MDR TB) when an effective treatment regimen cannot otherwise be provided.

How many companies does Johnson and Johnson own?

A company like Johnson & Johnson has over 100 brands. A major part of the brands is focused on consumer products.

Are there any side effects to taking Sirturo?

Hepatotoxicity: In clinical trials, more hepatic-related adverse reactions were reported in adults with the use of SIRTURO ® plus other drugs to treat tuberculosis compared to other drugs used to treat tuberculosis without the addition of SIRTURO ®.

How many deaths have been caused by Sirturo?

One death occurred during the 24 weeks of administration of SIRTURO ®. The imbalance in deaths is unexplained. No discernible pattern between death and sputum culture conversion, relapse, sensitivity to other drugs used to treat tuberculosis, HIV status, or severity of disease could be observed.

When to use Sirturo in patients with renal impairment?

Renal excretion of unchanged bedaquiline is not substantial (less than or equal to 0.001%). No dose adjustment is required in patients with mild or moderate renal impairment. In patients with severe renal impairment or end stage renal disease requiring hemodialysis or peritoneal dialysis, SIRTURO ® should be used with caution.

How old do you have to be to take Sirturo?

Pediatric Use: The safety, effectiveness and dosage of SIRTURO ® in pediatric patients less than 5 years of age and/or weighing less than 15 kg have not been established. Renal Impairment: SIRTURO ® has mainly been studied in adult patients with normal renal function.