- In September 2024, Genentech (a member of the Roche Group) received FDA approval for Ocrevus Zunovo, a new subcutaneous formulation of Ocrevus (ocrelizumab) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) in adults. This new formulation allows for a twice-yearly, 10-minute administration by a healthcare professional, offering increased convenience for patients
- In December 2024, The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to tolebrutinib for the treatment of adults with non-relapsing secondary progressive multiple sclerosis (nrSPMS). This designation is based on positive results from the Phase 3 HERCULES study, showing tolebrutinib delayed the time to onset of 6-month confirmed disability progression. Tolebrutinib is a brain-penetrant Bruton's tyrosine kinase (BTK) inhibitor
- In March 2025, The US FDA is evaluating under priority review the regulatory submission of tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and to slow disability accumulation independent of relapse activity in adult patients, with a target action date of September 28, 2025. A regulatory submission is also under review in the EU.
- In August 2024, Abata Therapeutics' ABA-101, an autologous regulatory T-cell (Treg) therapy for the treatment of patients with progressive MS, received fast track designation from the FDA. This aims to expedite efforts to bring ABA-101, a therapy targeting inflammatory tissue injury in progressive MS, to patients.
