The U.S. Food and Drug Administration removed the Risk Evaluation and Mitigation Strategies (REMS) program for Caprelsa (vandetanib), a thyroid cancer medication manufactured by Sanofi SA’s (NASDAQ: SNY) Genzyme Corporation.
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Caprelsa will remain available with the same prescribing information, but health care providers will no longer need special certification or extra monitoring beyond standard clinical care.
A REMS is a safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. The safety requirements for Caprelsa included mandatory training for health care providers and monitoring of patients.
The FDA first approved Caprelsa in 2011 to treat medullary thyroid cancer in patients whose disease has spread or cannot be surgically removed.
At the time, a REMS program was required to ensure appropriate heart rhythm monitoring and safe use.
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After more than a decade of oversight, REMS assessments reported no cases of Torsades de pointes or unexplained sudden deaths among U.S. patients taking Caprelsa. Clinical data also showed no concerning patterns of heart rhythm problems.
On Friday, Sanofi US announced a broad expansion of its Insulins Valyou Savings Program by offering a 30-day supply of any Sanofi insulin for $35 to all patients in the U.S. with a valid prescription.
The program, first created for people without health insurance, will be available to all Americans regardless of insurance status, including those with commercial insurance or Medicare, to ensure affordable access to these critical medicines.
Sanofi’s expanded Insulins Valyou Savings Program now ensures no American needs to pay more than $35 per month for their Sanofi insulins.
“Our announcement builds on an idea first championed by President Trump to lower costs for American patients at the pharmacy counter. At Sanofi, we share his objective and believe that no one should struggle to afford their insulin, and we are proud to take this next step as we play our part to keep America healthy,” said Adam Gluck, Sanofi’s head of U.S. Corporate Affairs.
The expanded Insulins Valyou Savings Program will be available to patients beginning Jan. 1, 2026.
SNY Price Action: Sanofi stock is up 1.23% at $45.63 at publication on Friday.
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