Merck’s two new rare disease drugs receive GIFT designation

MFDS selects products as 70th and 71st GIFT drugs…supports their accelerated approval

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The Ministry of Food and Drug Safety (MFDS) is speeding up domestic approval timelines by designating two rare disease treatments from Merck as subjects for Korea’s Global Innovative products on Fast Track (GIFT) program.

The MFDS announced that it designated Merck’s desmoid tumor treatment ‘Ogsiveo Tab’ and tenosynovial giant cell tumor (TGCT) treatment ‘Pimicotinib Cap’ as the 70th and 71st GIFT products, respectively. This designation is a measure to support the expedited approval of new drugs from innovative pharmaceutical companies that either have no existing treatment options or have demonstrated improved efficacy and safety.

Ogsiveo Tab (nirogacestat hydrobromide), which was designated as a GIFT product on April 21, is a treatment for adult patients with desmoid tumors requiring systemic therapy. The drug suppresses tumor growth by inhibiting gamma secretase (GS) and blocking Notch signaling pathways.

The drug has already received approval from the US FDA (November 2023) and the European EMA (August 2025), and was designated as an orphan drug in Korea on February 24, 2026. The MFDS selected it for expedited review based on the lack of existing treatment options.

Then, on April 27, “Pimicotinib Cap (pimicotinib hydrochloride monohydrate),” a treatment for tenosynovial giant cell tumor(TGCT), was added to the GIFT list. The treatment works by selectively inhibiting the colony-stimulating factor-1 receptor (CSF-1R) to block disease progression.

Pimicotinib is currently under development with FDA Fast Track and Breakthrough Therapy Designation (BTD) status in the United States, but has not yet received full approval in any global market. MFDS acknowledged the drug’s potential efficacy improvements and decided to manage it as a fast-track review product.

The two products designated under GIFT will benefit from review periods shortened by approximately 25% compared to standard reviews. In addition, a rolling review of prepared materials and customized consultations with professional reviewers prior to the submission of the marketing authorization application will be provided, which is expected to significantly accelerate the timeline for the drug’s introduction in Korea.

An MFDS official stated, “The exact indications and efficacy will be finalized after reviewing the submitted data. We will spare no effort in the review process to ensure that patients with intractable rare diseases can be provided with new treatment opportunities as quickly as possible.”