US regulators are extending the review time for Novartis' MS therapy ofatumumab.
Specific details for the delay were not given, but the Swiss drug giant said it would continue to work with the US Food and Drug Administration to complete the review “as soon as possible”.
“We are well prepared and ready to launch ofatumumab upon approval,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “We are committed to the MS community and look forward to bringing this important advancement to patients with MS.”
Ofatumumab (OMB 157) is a self-administered, targeted B-cell therapy developed for patients with relapsing multiple sclerosis.
Regulatory action is now expected in September 2020, while regulatory approval for this indication in Europe is expected in the second quarter of next year.
Ofatumumab is already approved in the US and EU as a first-line treatment for chronic lymphocytic leukaemia (CLL) and relapsed CLL under the trade name Arzerra.