Sanofi Pasteur Statement on Discontinuation of BCG
November 21, 2016 - Sanofi Pasteur has undertaken significant steps to restore production of ImmuCyst®/TheraCys® and to explore solutions to maintain the long-term availability of the product, these efforts, however, cannot guarantee the long-term continuity and reliable supply of the product. As a result, the company has decided to discontinue the production of ImmuCyst®/TheraCys®, BCG Live attenuated, indicated for the treatment of non-muscle invasive bladder cancer. Production will cease mid-2017; however we expect to continue to supply doses to Canada, France, and the UK - where the product is currently available -until the end of 2018.
Sanofi Pasteur’s decision to discontinue the production and supply of BCG-IT is not linked to safety issues. All the doses of ImmuCyst®/TheraCys® which have been released to the market meet all quality, safety and efficacy requirements. Sanofi Pasteur is communicating this decision to health agencies in Canada, France and the UK in order to allow them time to source BCG-IT products from alternative suppliers. We regret any potential impact this decision may have on the needs of patients and their health care providers. Because a continuous supply of the product will not be available for patients, the product will not be re-launched in the U.S.