- The Food and Drug Administration has extended its review of Novartis' experimental multiple sclerosis treatment ofatumumab by three months.
- Novartis now expects an answer from U.S. regulators in September on expanded use of the medicine, currently approved for leukemia patients. The company had originally anticipated approval in June for treating patients with relapsing multiple sclerosis, the most common form of the disease.
- The Swiss drugmaker didn't give any details on why the FDA review was extended in its June 2 statement. Novartis said it still expects European approval in the second quarter of 2021.
The news could be a sign of slowing review times at the FDA as the staff copes with a surge of work related to the outbreak of COVID-19. Pharmaceutical companies are rushing to develop treatments and vaccines, and the Trump administration has pledged to speed coronavirus products through the system.
"With many staff members working on COVID-19 activities, we may not be able to maintain our level of performance" on expected timelines for other medicines, the FDA warned in guidance for the industry last month.
Regardless of reason, the delay all but erases the Priority Review secured by Novartis for the medicine. The FDA awards the shorter six-month review windows to drugs that hold the promise of significant improvements in treatment. A standard review at the agency takes 10 months.
Ofatumumab is a critical drug in Novartis's pipeline, expected to challenge Roche's Ocrevus, a top multiple sclerosis medicine. Unlike Ocrevus, which requires an infusion and monitoring, ofatumumab is a self-administered injection.
Studies showed ofatumumab could significantly reduce disease relapses compared with Sanofi's Aubagio medicine. While the Novartis product hasn't been compared in a head-to-head trial with Roche's Ocrevus, it appeared to show benefits similar to those seen in studies of Ocrevus.
Almost 1 million people in the U.S. suffer from multiple sclerosis, according to the National Multiple Sclerosis Society.