Sanofi, a leading French pharmaceutical company, has received positive news about its multiple sclerosis (MS) drug called tolebrutinib. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approving this drug for patients with secondary progressive MS (SPMS) who have not experienced relapses in the past two years. In Europe, the drug will be sold under the name Cenrifki. The CHMP highlighted the drug’s benefits, including a 31% reduction in the worsening of disabilities and a 38% reduction in the development of new or worsening brain lesions compared to patients who took a placebo. However, the U.S. Food and Drug Administration (FDA) has rejected the drug for the same use in the U.S., citing concerns about its effectiveness and safety. The FDA also pointed out that the risk of liver damage caused by the drug could not be properly managed with the proposed safety plan. Additionally, Sanofi recently announced that tolebrutinib failed to show benefits in a trial for another type of MS called primary progressive MS (PPMS), and it also failed in two other late-stage MS trials earlier this year. Sanofi acquired the rights to tolebrutinib in 2020 through its $3.7 billion purchase of Principia Biopharma. Meanwhile, Novartis, another major pharmaceutical company, has received a recommendation for approval in Europe for its gene therapy called Itvisma, which treats a rare disease called spinal muscular atrophy (SMA). The CHMP’s recommendation follows the FDA’s approval of Itvisma in the U.S. five months ago. Itvisma is designed to be injected directly into the spinal fluid, unlike Novartis’ other SMA treatment, Zolgensma, which is given through an IV. Itvisma can be used at higher doses for heavier patients. The CHMP also supported the approval of Redemplo, the first small interfering RNA (siRNA) medicine to treat a rare genetic disorder called familial chylomicronemia syndrome (FCS). The FDA approved Redemplo in the U.S. five months ago to help reduce high triglyceride levels in adults with this condition. On a different note, Novartis has withdrawn its application for an expanded use of its prostate cancer drug Pluvicto in Europe. The drug was previously approved in the U.S. and Europe to treat certain prostate cancer patients who had not yet received chemotherapy, but Novartis decided to pull back its application for a broader use in Europe. Additionally, Soleno Therapeutics recently withdrew its application for Viokat, a drug to treat excessive hunger in patients with Prader-Willi Syndrome (PWS), after the CHMP determined that the trial data did not clearly show that the drug’s benefits outweighed its risks. Viokat was approved by the FDA in the U.S. last year as the first treatment for this condition.