active
ACTIVE SINCE: 1998

Sanofi and CDC Collaboration on New Tuberculosis Treatments

Developing rifapentine to simplify and shorten treatment of non-resistant latent and active TB.
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Objectives
  • With CDC, to develop rifapentine to simplify and shorten treatment of non-resistant latent and active TB.

What are the health needs and challenges?

Along with HIV/AIDS and malaria, tuberculosis is one of the most widespread infectious diseases in the world. 25% of the world’s population is infected with M. tuberculosis, and approximately 10 million people develop active disease annually. Of these, 1.6 million die each year. Treatment of drug-susceptible tuberculosis (TB) is long and complex, involving frequent intake of multiple drugs for at least six months. When administered properly, the treatment is generally highly effective. However, for many patients it is difficult to comply with six months of treatment. Poor compliance not only puts the patient at risk of treatment failure, but also creates conditions that encourage the development of antibiotic-resistant bacteria. The key challenge is to simplify the treatment and fight resistant strains in order to control drug-resistance TB.

Moreover to move to TB elimination, there is a need to take care of the infected people, as some of them are at risk to develop active TB if the infection is not prevented.

Partnership activities and how they address needs and challenges

The US Centers for Disease Control and Prevention (CDC) has lead an international group of scientists in the development of new indications for rifapentine, a Sanofi drug registered in the US since 1998 for the treatment of pulmonary drug-susceptible tuberculosis in combination with other drugs. In 2011, the CDC showed that rifapentine had the ability of considerably simplifying the treatment of latent tuberculosis, with the potential of improving patient compliance. Sanofi has submitted the dossier for registration of latent TB indication in different countries, up to know rifapentine (administered) is approved in the USA, Taiwan, Hong-Kong, Philippines,South-Africa, Indonesia and Thailand.

In October 2020, Tuberculosis Trial Consortium (TBTC) CDC communicated the results of a phase 3 study for the treatment of DS active TB. The aim was to shorten the treatment duration down to 4 months

Lessons learned

The CDC work on rifapentine in the treatment of latent TB is an example of a successful partnership which may deliver considerable gain for patients.

Quote
"Multiples challenges beyond the donation of drugs have been progressively tackled in ways that build sustainable capacity. The results speak for themselves."
Dr Margaret Chan
Director-General, World Health Organization
Results and milestones

A 2011 CDC study on rifapentine shows that the treatment of latent TB is a major milestone in the treatment of this infection. Sanofi has other projects in development with CDC on rifapentine in the treatment of latent and active TB.

Following the positive results of the Prevent CDC, Sanofi in May 2014, Sanofi submitted to the US FDA a supplemental new drug application (sNDA) for rifapentin in the treatment of latent TB (in combination with isoniazid). In addition to the US, today rifapentine is registered in Taiwan, Hong-Kong, Philippines,South-Africa, Indonesia and Thailand.

The Tuberculosis Trials Consortium (TBTC), from the US Centers for Disease Control and Prevention (CDC), announced first results from the “Rifapentine-containing treatment shortening regimens for pulmonary tuberculosis” study (TBTC Study 31) in October 2020. This demonstrated that a 4-month regimen for active TB disease including high-dose rifapentine and moxifloxacin was non-inferior to the current 6-month standard treatment regimen. Both the CDC and the WHO are assessing this new evidence for inclusion in updated US national, and global, TB treatment guidelines.
Sanofi is proud to have contributed to this landmark trial that confirmed the efficacy of the shortened treatment regimen, and to have played its part in advancing scientific knowledge.

Geographic Reach
  • Global Commitment
Disease Area
  • Infectious and Parasitic Disease
See Disease Areas
Target Population
  • Children
  • Men
  • Women
Partner organizations
Government

Centers for Disease Control and Prevention (CDC)