What is the likelihood of sanofi new drug or treatment receiving FDA approval?

The likelihood of Sanofi's new drug or treatment receiving FDA approval can be assessed based on the following factors:

1. Recent FDA Approvals: Sanofi has recently received FDA approval for its multiple myeloma treatment, Sarclisa, in combination with VRd. This approval expands Sarclisa's indication, making it a competitor to Johnson & Johnson's Darzalex in the first-line myeloma treatment market.
2. Positive Clinical Trial Results: Sanofi's tolebrutinib, a BTK inhibitor, has shown a 31% delay in time to six-month disability progression in the non-relapsing secondary progressive MS population. The company plans to submit marketing applications to global regulatory authorities by the end of 2024, following the release of positive Phase III data from the HERCULES trial.
3. Strategic Focus: Sanofi has demonstrated a commitment to oncology drug development, as evidenced by its expansion into new indications for existing drugs and the development of novel therapies like tolebrutinib.
4. Market Position: Sanofi's approval of Sarclisa and tolebrutinib could strengthen its position in the competitive oncology market and provide a new revenue stream.
5. Regulatory Engagement: Sanofi's engagement with the FDA, including the submission of sNDA for the increased dosage of Ameluz®, suggests a collaborative approach to the approval process.

Considering these factors, it is reasonable to conclude that Sanofi has a good likelihood of receiving FDA approval for its new drug or treatment. However, it is essential to note that the FDA approval process is complex and unpredictable, and no guarantee can be provided regarding the ultimate outcome.