The U.S. Food and Drug Administration (FDA) is extending its review of Novartis‘ ofatumumab, a possible self-administered injection therapy for relapsing multiple sclerosis (MS), the company announced.
Originally expected in June, the FDA decision is now expected in September.
“Novartis will continue to work with the FDA to complete the review as soon as possible,” Marie-France Tschudin, president of Novartis Pharmaceuticals, said in a press release.
“We are well prepared and ready to launch ofatumumab upon approval. We are committed to the MS community and look forward to bringing this important advancement to patients with MS,” Tschudin added.
Ofatumumab is an antibody therapy that works by binding to CD20, a protein present on the surface of immune B-cells. By binding CD20, ofatumumab targets B-cells for destruction, which is believed to reduce inflammation in the central nervous system (the brain and spinal cord).
Ofatumumab is approved in the U.S. to treat certain blood cancers under the brand name Arzerra.
Ofatumumab is different from other CD20-targeting therapies for MS in that it is designed to be self-administered once a month using an autoinjector pen, rather than through an infusion in a hospital setting. The therapy is being developed as a 20 mg under-the-skin (subcutaneous) injection.
Novartis submitted a supplemental biologics license application (sBLA) to the FDA in late February. A BLA covers medications, like antibodies, that are manufactured with the use of living cells and are known as biologic products. In contrast, an investigational new drug application is for chemicals with a known structure that can be synthesized without using living cells.
Novartis also submitted a marketing authorization application to the European Medicines Agency (EMA) at the same time. A decision from the EMA is expected in mid-2021.
These regulatory submissions are supported by positive data from the Phase 3 clinical trials ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231). Collectively, these trials enrolled 1,882 people with relapsing MS, including relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS).
Trial participants were randomly assigned to either ofatumumab (20 mg injections once a month) or Aubagio (14 mg oral capsules taken daily) for 30 months. Aubagio (teriflunomide) is an approved MS medication marketed by Sanofi Genzyme.
Results from the trials demonstrated that the average annual relapse rate was more than 50% lower in patients given ofatumumab than in those given Aubagio — 0.11 vs. 0.22 relapses/year in ASCLEPIOS I, and 0.10 vs. 0.25 relapses/year in ASCLEPIOS II. Ofatumumab also led to significant reductions in the number of active brain lesions, and in the risk of disability progression after three and six months.
Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline; Novartis obtained all rights to ofatumumab in December 2015.
