EA Pharma Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
(Code 4547, Tokyo Stock Exchange Prime Market)
EA Pharma Co., Ltd. (Head Office: Chuo-ku, Tokyo, Japan; President: Hidenori Yabune; “EA Pharma”) and Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano; Chairman and CEO: Mutsuo Kanzawa; "Kissei") announced that “CAROGRA® Tablets” (nonproprietary name, carotegrast methyl; “CAROGRA®”), was launched today for treatment of ulcerative colitis in Japan, following the inclusion in the National Health Insurance Drug Price List as of May 25.
CAROGRA® is a small molecule compound that was originated by EA Pharma (formerly known as Ajinomoto Pharmaceuticals Co., Ltd.) and is the first α4 integrin antagonist drug launched as an orally available dosage form in the world. CAROGRA® acts on both α4β1 and α4β7 integrins expressed on the surface of inflammatory cells to exert anti-inflammatory effects by suppressing excessive aggregation and invasion of inflammatory cells into the inflamed site of colonic mucosa in ulcerative colitis.
EA Pharma and Kissei have jointly developed CAROGRA® since 2015. As of March 28, 2022, EA Pharma obtained the manufacturing and marketing approval in Japan. CAROGRA® will be distributed by Kissei with co-promotion by EA Pharma in Japan.
EA Pharma and Kissei strive to increase treatment options for ulcerative colitis and contribute to QOL (Quality of Life) of patients and their families by providing CAROGRA® for clinical practice quickly.
| Brand Name | CAROGRA® Tablets |
| Nonproprietary Name | Carotegrast Methyl |
| Color, Formulation | White or yellowish white to yellowish greenish white film coated tablets |
| National Health Insurance (NHI) Drug Price | ¥200.00/tablet (¥4,800.00/day) |
| Date of Manufacturing and Marketing Approval | March 28, 2022 |
| Date of Inclusion in the NHI Drug Price List | May 25, 2022 |
| Date of Launch | May 30, 2022 |
| Manufacturer and Marketing Authorization Holder | EA Pharma Co., Ltd. |
| Distributor | Kissei Pharmaceutical Co., Ltd. |
| Indication | Moderate ulcerative colitis (limited to those patients who had inadequate response to 5-aminosalicylic acid) |
| Dose and Administration | Normally in adults, 960 mg of carotegrast methyl per dose should be taken orally after a meal 3 times a day. |
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4. About Ulcerative Colitis
Ulcerative colitis is an inflammatory disease that causes ulcers and erosions in the colonic mucosa. The major symptoms are abdominal pain, diarrhea, bloody stools and so on. In many cases, the “remission” stage where the symptoms improve and the “relapse” stage where the symptoms deteriorate repeatedly over time, and patients suffer from the decline of QOL. The mechanism of onset is unknown up to the present. In Japan, ulcerative colitis is one of the “designated intractable disease” by Ministry of Health, Labour and Welfare. The registered patient number in Japan was nearly 220,000 in 2019, and the patient number has a tendency to increase in recent years.1)
1) Basic treatment guidance for patients with ulcerative colitis” (revised March 2020), Research group for intractable inflammatory bowel diseases, Research project on rare and intractable diseases, Health and Labour Sciences Research Grants