South Korea approves nerandomilast for idiopathic pulmonary fibrosis
In short
South Korea's Ministry of Food and Drug Safety said on October 15 it had approved an imported orphan medicine containing nerandomilast for idiopathic pulmonary fibrosis. The regulator reviewed the drug through its GIFT fast-track support programme.
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South Korea's Ministry of Food and Drug Safety said on October 15 it had approved an imported orphan medicine for idiopathic pulmonary fibrosis. The product, Jaskeideu tablets (자스케이드정), contains nerandomilast. Newsis identified it as a Boehringer Ingelheim medicine and reported that the company's South Korean operation had previously submitted an application to the regulator. The ministry said it expected the medicine to provide a new treatment opportunity through a mechanism different from those of existing treatments. [ 1 , 2 , 3 , 4 ]
The medicine selectively inhibits phosphodiesterase 4, an enzyme also known as PDE4, according to the reports. The ministry described it as reducing the expression of fibrosis-promoting growth factors and inflammation-related substances that are overexpressed in fibrotic lung disease, producing antifibrotic and anti-inflammatory effects. Yonhap described idiopathic pulmonary fibrosis as a condition in which chronic inflammatory cells enter the alveolar walls, causing structural tissue changes and declining function. Seoul Economic Daily said the disease involves progressive lung stiffening and makes normal breathing increasingly difficult as it advances. [ 1 , 2 , 3 , 4 ]
The regulator designated the medicine as the 16th product in its Global Innovative Products on Fast Track support system, known as GIFT, and carried out an expedited review. Seoul Economic Daily described GIFT as a programme that supports innovative medical products from the early stages of clinical development to help them reach the market quickly. The ministry said it had sought to enable rapid introduction into clinical practice and would continue promptly reviewing and approving treatments whose safety and effectiveness had been sufficiently established to expand patients' treatment opportunities. [ 1 , 2 , 3 , 4 ]
Why it matters
The ministry said the medicine offers a different mechanism from existing treatments and could provide patients with another treatment opportunity. The approval concerns a disease in which lung tissue changes and lung function progressively declines.
Key facts
- The regulator approved Jaskeideu tablets (자스케이드정), containing nerandomilast, for idiopathic pulmonary fibrosis. [ 1 , 2 , 3 , 4 ]
- The medicine selectively inhibits the enzyme phosphodiesterase 4, according to the reports. [ 1 , 2 , 3 , 4 ]
- It was designated the 16th product under the GIFT fast-track support programme. [ 1 , 2 , 3 , 4 ]