AZ’s gMG candidate ‘gefurulimab’ receives GIFT designation

MFDS supports fast-track review …meets Korea Innovative Pharma-developed new drug criteria

AstraZeneca's ‘gefurumab,’ its new drug candidate for myasthenia gravis, has been selected for fast-track review support by Korea’s Ministry of Food and Drug Safety (MFDS).

This designation is expected to accelerate its commercialization.

On the 5th, the MFDS announced that AstraZeneca’s gefurulimab had been designated as the 63rd product under the GIFT (Global Innovative product on Fast-Track) program.

GIFT is a fast-track review program operated by the MFDS since September 2022 to provide patients with new treatment opportunities through expedited product development support.

Products eligible for GIFT designation include drugs for life-threatening diseases, rare diseases with no existing treatment alternatives, and innovative new drugs developed by certified innovative pharmaceutical companies.

The MFDS designates GIFT products through a comprehensive evaluation of factors such as innovative therapeutic benefit, contribution to public-health crisis response, and the developer’s R&D efforts.

Selection into GIFT reduces the review period by at least 25% (from 120 working days to 90 working days).

This is achieved by applying a rolling review process, where submitted data are reviewed first, and close communication between reviewers and developers, which is facilitated through product briefings and supplementary explanations. Additionally, companies receive various supports for rapid commercialization, such as specialized regulatory consulting.

AstraZeneca announced positive results last July from the Phase III PREVAIL trial, which evaluated the use of gefurulimab in adult patients with anti-acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (gMG). Gefurulimab met the primary endpoint and all secondary endpoints in the trial.

Gefurulimab is a terminal complement inhibitor that selectively binds to both complement protein C5 and serum albumin. It is a novel bispecific nanobody drug candidate optimized for self-administered subcutaneous injection to treat anti-acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG).

Generalized myasthenia gravis is a chronic autoimmune neuromuscular disorder, a rare disease causing muscle function loss and severe muscle weakness.

Gefurulimab has been favorably evaluated for its convenience, as it allows once-weekly self-administration, compared with existing treatments for adult myasthenia gravis, such as Ultomiris and Soliris.

AstraZeneca Korea's status as a Korean Innovative Pharmaceutical Company influenced gefurulimab’s selection for the GIFT program.

This drug has not yet received approval from advanced overseas regulatory agencies such as the US FDA, Europe’s EMA, or Japan’s PMDA. The Ministry of Food and Drug Safety (MFDS) applied its fast-track review program ahead of these overseas agencies.

However, the US FDA has designated this drug as an orphan drug and is providing support. The MFDS also designated this drug as a development-stage orphan drug this month.

To date, 49 of the drugs designated as GIFT have received marketing authorization.