Novartis : Multiple-Sclerosis Drug Kesimpta Gets FDA Approval

By Cecilia Butini

Novartis AG late Thursday said the U.S. Food and Drug Administration approved the company's relapsing-multiple-sclerosis drug Kesimpta (ofatumumab) after two Phase 3 studies.

The drug, a B-cell therapy which patients can self-administer at home via an autoinjector pen, is expected to be available in the U.S. in early September, the Swiss pharmaceutical company said. Regulatory approval in Europe is expected in the second quarter of 2021, Novartis said.

Write to Cecilia Butini at [e-mail]