Two rare disease treatments – Nefecon Cap (budesonide) and Pegcetacoplan Inj -- have been designated as subject to the innovative global product on a fast track (GIFT).

The  Ministry of Food and Drug Safety said Tuesday that it designated the two drugs as Nos. 2 and 3 products subject to GIFT.

GIFT is a system that supports innovative global medical products from the early development (clinical trial) stage to help commercialize them quickly.

Nefecon Cap is a medicine used to treat primary IgA nephropathy in adults whose protein-to-creatinine ratio is 1.5 or higher and exposed to the risk of rapid progression. Its original developer is Calliditas Therapeutics.

IgA nephropathy is a rare autoimmune disease that causes glomerulonephritis due to immunoglobulin A. It is estimated that there are about 9,000 patients in Korea.

Pegsetacoplan injection is a drug used to treat paroxysmal nocturnal hemoglobinuria (PNH). Apellis Pharmaceuticals is its original developer.

The MFDS said it designated the injection product as subject to GIFT to provide treatment with improved efficacy than existing drugs more quickly.

Suppose a medical product is designated as subject to GIFT. In that case, it can receive various benefits, such as shortened review period from 120 to 90 working days, a rolling review that examines prepared data first, close communication between developers and reviewers, and other supports for its quick commercialization, including consulting by regulation-related experts.

The MFDS plans to provide information on GIFT subjects on its website and update it every quarter.

“We will continue to operate the GIFT program more efficiently based on regulator science and expertness to help develop and commercialize innovative products quickly,” the ministry said.