Sanofi has sought FDA approval to expand the label of its enzyme replacement therapy, Cerezyme, to include patients with Gaucher disease type 3 (GD3), with no age limitation for patients with GD1 and GD3, and a decision is expected on January 13, 2026.Gaucher disease is a rare, genetically inherited autosomal recessive disorder caused by mutations in the GBA gene. Gaucher patients lack the normal form of the glucocerebrosidase, or GCD enzyme that breaks down specific fat molecules, resulting in the accumulation of fat in the liver, spleen and bone marrow. The disease is classified into three types based on the presence and severity of neurological involvement. Type 1 Gaucher disease does not typically involve neurological symptoms, whereas type 2 is characterised by severe neurological problems that appear early in life and progress rapidly. Type 3 presents with milder neurological issues that emerge during childhood and advance more gradually.Cerezyme is already approved for the treatment of adults and pediatric patients 2 years of age and older with Type 1 Gaucher disease that results in one or more of the following conditions, namely anaemia (low red blood cell count), thrombocytopenia (low blood platelet count), bone disease, and hepatomegaly or splenomegaly (enlarged liver or spleen).The drug generated €742 million in net sales in 2024 and €524 million in the first nine months of 2025, reflecting a continued strong performance.SNY closed Monday’s (Dec.29, 2025) trading at $48.35, down 0.25%.