FDA Approves Genentech’s Subcutaneous Ocrevus for Multiple Sclerosis Treatment

Introduction to Ocrevus Zunovo

The FDA has approved a new subcutaneous formulation of Genentech's Ocrevus, known as Ocrevus Zunovo, for treating patients with multiple sclerosis (MS). This approval enables a twice-yearly, approximately 10-minute injection administered by healthcare practitioners, providing a convenient alternative to the previously established intravenous version.

Advancements in Multiple Sclerosis Treatment

This latest approval follows Genentech’s recent push towards subcutaneous formulations. The significance of this development is underscored by Natalie Blake, executive director of the MS Foundation, who stated, “People are living longer with chronic illnesses… providing choices to address each person’s needs is essential.”

Ocrevus Zunovo Details

• Ocrevus Zunovo combines traditional Ocrevus with Therapeutics’ Enhanze drug delivery technology.
• The annual cost of Ocrevus remains at approximately $78,858.
• Genentech offers a copay program that allows eligible patients to receive treatment for $0, up to a limit of $20,000 per year.

Clinical Trial Results

The FDA's approval was based on the results from the phase 3 OCARINA II trial involving 236 patients. The trial found no clinically significant differences in the drug levels when administered subcutaneously compared to the intravenous formulation.

Patients experienced consistent results with relapse activity suppression of 97% and similar effectiveness on MRI lesions through 48 weeks. Furthermore, more than 92% of participants expressed satisfaction with the new administration method.

Expert Insights

Dr. Scott Newsome from Johns Hopkins University noted, “Patients treated with subcutaneous Ocrevus experienced appropriate B-cell suppression… demonstrating the potential of subcutaneous Ocrevus as a treatment option.”