Sanofi SNY announced that the FDA has approved its type I diabetes (T1D) drug, Tzield (teplizumab), for a new indication under the accelerated pathway. The agency has cleared the therapy to delay the loss of the body’s own insulin production for pediatric patients aged eight to 17 years who were recently diagnosed with Stage 3 T1D.
Per the company, the latest approval makes Tzield the first disease-modifying therapy for this patient population. The drug is already approved to delay the onset of stage 3 T1D in children aged one year and older with stage 2 disease.
The FDA’s decision is supported by positive results from the phase III PROTECT study, which showed that treatment with the drug slowed the decline in C-peptide levels, an indicator of how much insulin the body is still producing. Sanofi is currently enrolling patients in the late-stage BETA-PRESERVE study, which will serve as a confirmatory study required for full approval.
SNY’s Stock Performance
Year to date, shares of the company have declined nearly 9% against the industry’s 5% growth.
Zacks Investment Research
Image Source: Zacks Investment Research
How Sanofi Benefits From Tzield’s Label Expansion?
The latest label expansion broadens the drug’s addressable market by allowing Sanofi to treat children who have already progressed to stage 3 T1D following diagnosis.
While stage 2 T1D can be identified through proactive screening before symptoms emerge, widespread screening remains uncommon because patients are typically asymptomatic at this stage. In contrast, many patients are diagnosed only after progressing to stage 3 and developing clinical symptoms, potentially making the newly approved patient population easier to identify and treat.
Patients with stage 3 T1D eventually require constant monitoring and insulin injections for life. This stage is marked by the destruction of a significant portion of insulin-producing beta cells and reaching the point of clinical hyperglycaemia (high blood sugar).
Tzield was added to Sanofi’s portfolio in 2023 after it acquired Provention Bio for $2.9 billion. The drug was originally developed by MacroGenics MGNX. Provention Bio had acquired this drug from MacroGenics under an asset purchase agreement signed in 2018.
SNY’s Zacks Rank
Sanofi currently carries a Zacks Rank #3 (Hold).
Sanofi Price 
Sanofi Price
Sanofi price | Sanofi Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Immunocore IMCR and Indivior Pharmaceuticals INDV, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.