Stop TB Canada calls for Sanofi to apply for regulatory approval of Rifapentine in Canada
Dear Mr. Hudson,
We write to you with the urgent request that Sanofi apply for regulatory approval of rifapentine in Canada. As members of Stop TB Canada, a network of Canadians committed to ending tuberculosis (TB) in Canada and abroad, we are keenly aware of the important role that rifapentine can play in TB prevention and, increasingly, care around the world.
At this time; however, Canadians are denied full use of this valuable tool. This is reflected in the fact that the recently released Canadian TB Standards (8th Edition) recommends 3HP as a preferred treatment option for latent TB infection (LTBI) due to its favourable safety and efficacy profile compared to 9H. While your company makes this valuable medicine, it has never submitted an application for regulatory approval in Canada. This means that a drug recognized in national and international guidelines as the drug of choice is not formally available to Canadians, not because it is not safe or effective, but because your company has made a business decision not to bring a drug found on the World Health Organization’s Model List of Essential Medicines to the Canadian market.
As a consequence, it can only be accessed for 3HP as an unapproved medicine through Health Canada’s Urgent Public Health Need (UPHN) program. Rifapentine accessed through the UPHN cannot be used for other indications, such as 1HP, rifapentine for active TB treatment, and new fixed dose combinations, preventing physicians from accessing a useful tool and unnecessarily inhibiting tuberculosis care. In turn, lack of access to these tools has a particular impact on already vulnerable communities in Canada, particularly Indigenous communities in Northern Canada who are disproportionately impacted by TB. Inuit communities in Canada, for example, suffered a TB incidence rate over 480 times higher than the Canadian-born non-Indigenous population. This underlines that although Canada has a low incidence of TB overall, some communities in the country shoulder an extremely high burden of the disease, and this must be taken into account when considering whether to make life-saving TB drugs available in otherwise ‘low-incidence’ country markets.
Sanofi has the opportunity to make this tool available. By doing so, your company has the opportunity to play a key role in helping Canada meet its goal of eliminating TB both domestically across Inuit Nunangat and globally by 2030. For this reason, we ask you to commence the process of registering rifapentine for use in Canada or publicly clarify the reasons for not doing so. If barriers to registration exist, we would welcome the opportunity to meet with you to discuss how we can work together to overcome them.
Sincerely,
Stop TB Canada steering committee