Sanofi
Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration
Designation earned for a one-time intravitreal gene therapy with the potential to eliminate treatment burden for people living with neovascular age-related macular degeneration Neovascular or “wet” age-related macular degeneration can lead to significant vision loss and affects more than one million people in the US. 11 September 2025 -- Paris, France -- The US Food...
Sanofi’s rilzabrutinib earns orphan designation in the EU for IgG4-related disease
Paris, August 14, 2025: The European Medicines Agency has granted orphan designation to rilzabrutinib, a reversible covalent Bruton’s tyrosine kinase (BTK) inhibitor, for IgG4-related disease (IgG4-RD). EMA grants orphan designation to investigational therapies addressing rare, life-threatening or debilitating medical diseases or conditions that affect no more than 5 in 10,000 persons in the EU. Rilzabrutinib...
New Anthem from Girl Band Raises Awareness of Type1 Diabetes After Research Highlights Silent Struggle
Recent research from Sanofi highlights the significant impact of Type 1 Diabetes on those living with the condition The song, “Rise Up,” shares their experiences of living with the condition and will be released on Spotify under the band’s name with an accompanying music video Sanofi and Stagecoach partner to form 1Type a girl group...
Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD
New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma Itepekimab expanding into chronic rhinosinusitis along with COPD and bronchiectasis; phase 3 readouts in COPD in H2 2025 and bronchiectasis in 2026. 15 April 2025 -- Paris, France -- Sanofi today shared...
Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines
Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia. 3 April 2025 -- Paris, France -- The US Food and Drug Administration (FDA) has granted orphan drug designation to rilzabrutinib, an investigational, novel, advanced, oral, reversible...
Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD
Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in adults with elevated eosinophils Approval marks the first new treatment approach for COPD in more than a decade in Japan and the sixth approved indication for chronic diseases with underlying type 2 inflammation. 28 March...
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity Tolebrutinib has the potential to be the first therapy to target smoldering neuroinflammation, a key driver of disability accumulation in MS Tolebrutinib was granted breakthrough therapy...
Sanofi to acquire Dren Bio’s bispecific myeloid cell engager for deep B-cell depletion, broadening immunology pipeline
Dren Bio deep B-cell depleter program has the potential to reset the immune system Acquisition underpins path for Sanofi becoming leading immunology company Sanofi to pay $600 million up front. 20 March 2025 -- Paris, France -- Sanofi and Dren Bio, Inc., a private clinical-stage biopharmaceutical company, have entered into a definitive agreement under which...
Opella reaches study milestone for Cialis
21 January 2025 -- Paris, France -- Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil) from a prescription to an over-the-counter medicine. This decision allows for the initiation of the...
Sarclisa obtains first approval in China for the treatment of adult patients with relapsed or refractory multiple myeloma
Approval based on positive pivotal ICARIA-MM phase 3 study using the China-based IsaFiRsT real-world study as bridging data, which demonstrated Sarclisa and the standard treatment Pd, improved responses and long-term outcomes compared to Pd alone in R/R MM patients Sarclisa-Pd is currently recommended by the Chinese Society of Clinical Oncology (CCSCO) and Chinese Anti-Cancer Association...
