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Novartis Gets FDA Approval for Leukemia Drug To Be Used in Multiple Sclerosis

Ofatumumab was approved by the FDA in 2009 for chronic lymphocytic leukaemia (CLL). It will be marketed as Kesimpta for multiple sclerosis.

Video source: Novartis

By John Miller

ZURICH (Reuters) – Novartis on Thursday won U.S. Food and Drug Administration (FDA) approval to repurpose an 11-year-old blood cancer drug against multiple sclerosis as the Swiss drugmaker takes on rival Roche’s big-selling Ocrevus for the autoimmune disorder.

The FDA approved Kesimpta, known generically as ofatumumab or by its brand name Arzerra, for use against chronic lymphocytic leukemia (CLL), to treat patients with relapsing multiple sclerosis. Arzerra was approved for CLL in 2009, and is sold by Novartis under a licensing deal with Genmab.

Novartis is pushing Kesimpta as a once-monthly, do-it-yourself shot that can be given at home, as opposed to an infusion like Ocrevus done in a clinic or hospital. Roche in July said Ocrevus’s first-half sales were impacted by reduced out-patient visits during the COVID-19 pandemic.

Kesimpta’s wholesale acquisition cost (WAC) is $83,000. Ocrevus is $65,000, though Novartis contends infused MS therapies may have “real-world” costs beyond the WAC price, making its drug competitive.

Ocrevus, which like Kesimpta works by depleting immune system B cells that attack MS patients’ nervous systems, has been touted by Roche as its best drug launch ever and is on pace to top $4 billion in sales in 2020. Novartis is hoping to win away business.

“Patients can self-administer the treatment at home, avoiding visits to the infusion center,” Stephen L. Hauser, Director of the UCSF Weill Institute for Neurosciences and a leader of studies of Kesimpta that led to its approval.

Roche contends twice-yearly injections for Ocrevus, approved for relapsing MS as well as the primary progressive form of the disease, deliver a deep, effective response for patients.

Roche in May won European approval for a shorter, two-hour infusion for Ocrevus as it prepared for the arrival of Novartis’s rival medicine. Roche is also working on a shot version.

Reporting by John Miller; editing by David Evans.


Source: Reuters

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