SEC recommends approval for Johnson & Johnson Tremfya with Phase III clinical trial waiver

The Subject Expert Committee (SEC), which advises the drug regulator on the drug trial and approval matters among others, has recommended to the regulator to grant permission to the US-based drug major Johnson & Johnson to import and market its psoriatic arthritis blockbuster drug Guselkumab solution for injection, branded in US as Tremfya, with Phase III clinical trial waiver subject to conditions.

The recommendation comes after Johnson & Johnson approached the Committee with data and justification for the local clinical trial waiver, since the Committee in August, last year, recommended the company to conduct Phase III trials.

The company has applied for approval of the drug Guselkumab Solution for Injection 100 mg/ml in single use pre-filled syringe and prefilled pen, with safety data from the Phase IV trial of other countries including Asian patients and ethnicity wise data from the clinical trials conducted globally, with request to grant import and marketing permission with local clinical trial waiver.

The Committee for Analgesic and Rheumatology, while considering the request in a meeting in the middle of January, observed that the drug is approved in the USA, Japan, European Union, Canada, Switzerland and Australia and has novel mechanisms of action.

The company is conducting global clinical trials in other indications by including Indian subjects. It also noted that there is an unmet need for the drug in psoriatic arthritis treatment.

After detailed deliberation, the committee recommended grant of permission to import and market Guselkumab solution for injection of 100 mg/ml indicated for Psoriatic Arthritis with Phase-III clinical trial waiver subject to three conditions.

The conditions include that the firm shall conduct Phase-IV clinical trial in India for the proposed indication with at least 100 patients and accordingly, protocol to conduct phaseIV study shall be submitted to the Central Drugs Standard Control Organisation within three months of grant of marketing authorisation.

Patients shall be screened for QuantiFERON-TB Gold test before initiation of treatment and at regular intervals during the treatment and finally, prescribing information of the drug product shall be submitted to CDSCO for further review, it said.

It may be noted that in an earlier meeting in August, 2023, while considering the safety data presented by the company from the Phase IV trial of other countries including Asian patients and ethnicity wise data from the clinical trials conducted globally, the Committee opined that there is no clinical data available on population of the Indian subcontinent.

The Committee in the August meeting, recommended the company to conduct Phase-III clinical trials in India. Accordingly, the committee asked the company to submit a clinical trial protocol for review.

Developed by Janssen, a part of Johnson & Johnson, Tremfya is the first approved fully human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of the pathogenesis of inflammatory diseases such as moderate to severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA).

The company on January 22, announced that the drug demonstrated rapid and significant clearance in moderate to severe scalp psoriasis (PsO) and significant improvement in scalp itch, as well as patient-reported health-related quality of life outcomes, including post-inflammatory pigmentation at 16 weeks.

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