Roche gets Phase 3 trial waiver for higher dose of multiple sclerosis drug

Global pharma major Roche has been given a Phase 3 trial waiver for a higher dosage form of its multiple sclerosis (MS) drug Ocrelizumab by a Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) to import and market the drug in India.

The 920 milligram (mg) version of Ocrelizumab was given this waiver by the neurology and psychiatry SEC at a meeting held on August 20. Roche had already received a similar waiver and approval for the 300 mg version of the same drug in 2023.

It later launched Ocrelizumab under the brand name Ocrevus in 2024. The drug is indicated for the treatment of relapsing forms of MS and primary progressive MS in adults. MS is a disease of the central nervous system that causes destruction of the coating that surrounds and protects nerve fibres.

The current waiver has been given under the provisions of Rule 101 of the New Drugs and Clinical Trials Rules, 2019, which allows the CDSCO to waive local clinical trials for new drugs already approved in six specified, well-regulated foreign countries.

However, the waiver approval is subject to the condition that the firm shall conduct a Phase 4 clinical trial in the Indian population for the proposed indications. “Accordingly, the firm shall submit phase 4 clinical trial protocol to CDSCO within three months of grant of marketing authorisation permission,” the SEC recommendations stated.

The SEC also noted that Ocrelizumab 300 mg concentrate for solution for infusion was already approved in India for similar proposed indications through intravenous (IV) administration.

Roche further added that the proposed drug product (920 mg form of Ocrelizumab) is already approved in 65 countries, including the United States of America (USA), United Kingdom (UK), Australia, Switzerland and European Union (EU).

The company had not responded to queries shared till the time of going to press.