The U.S. Food and Drug Administration (FDA) has extended the review process by three months for a Novartis multiple sclerosis drug.
Regulatory action on the drug, known as ofatumumab, is now expected in September 2020.
“Novartis will continue to work with the FDA to complete the review as soon as possible,” Marie-France Tschudin, Novartis Pharmaceuticals president, said in a company statement. “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.”
Fox News reached out for clarification on the reasoning behind the delay. Jamie Bennett, a Novartis spokesperson, said “this is all the information we have at this time.”
Regulatory approval for the drug in Europe is expected by 2021.